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Behind the Knife, the surgery

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0:10

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0:12

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Behind the Knife trauma surgery video atlas

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your fingertips via our website and app. Check

1:00

out behindtheknife.org for more. Thanks

1:30

for the invite. So.

1:59

before we dive in, I want to encourage

2:02

listeners to check out episode 290, which

2:05

was published in April, 2020. This is a

2:07

big T trauma episode. And

2:09

in this one, we reviewed the underpinnings

2:12

for Boas use and cover

2:14

potential indications, placement, and complications,

2:16

and offered a critical review

2:19

of the literature, which at that time was

2:21

up to date. Yeah.

2:24

The Patrick you've officially been scooped. We've

2:26

got more fodder for discussion now. This

2:29

is the first randomized trial studying the

2:31

use of Rboa in trauma patients. And

2:34

the trial was published just in October of 2023 in JAMA to

2:36

much fanfare

2:39

and is titled emergency department resuscitative

2:41

endovascular balloon occlusion of the aorta

2:44

in trauma patients with exsanguinating hemorrhage,

2:46

the UK Rboa randomized clinical trial.

2:49

You can find a link to the paper in

2:51

our show notes. And the lead author is Dr.

2:53

Jan Jansen, who is writing on behalf of the

2:55

UK Rboa study group. Okay.

2:58

So we're going to go through the

3:00

paper in terms of design and results

3:02

relatively expediently so we can focus on

3:05

discussion about trial findings, but then really

3:07

more importantly is how we may or

3:09

may not want to use Rboa clinically

3:12

and in the trauma setting. So this

3:14

is really a, it's a spicy topic.

3:16

It stirs the pot and the trauma

3:18

community, which we love and is fostered

3:20

some really good and important discussion. So

3:23

let's start from the beginning. Dr. Broghey, why

3:25

was this study needed and

3:28

what questions were you looking to answer? Yeah.

3:33

So I think it's

3:36

very difficult with devices and any complex intervention

3:39

as to when do you actually study them.

3:42

Do you study them early on in their

3:45

evolution when perhaps the technology hasn't

3:48

involved yet, but there being

3:51

the uptake is happening and then patient selection

3:54

is under consideration or

3:56

do you do it really late in the course

3:58

of a device It's being

4:01

used everywhere and then it becomes very

4:03

difficult to actually change

4:05

practice even with the results of a

4:07

trial. So I think the stop

4:10

phrase is there's never a great time to do a

4:14

device trial because they're constantly

4:16

evolving and innovating and credit

4:18

to Jan Jansen and Larry

4:20

Campbell and the team, they saw

4:22

a window of opportunity really as

4:24

this was being talked

4:27

about a lot, deployed in multiple

4:29

different circumstances in the UK

4:31

to actually say well let's actually do

4:33

the proper study and at least we'll

4:35

get a pragmatic view of

4:37

where the technology stands in its utility

4:39

within the context that people were talking

4:42

about at the time. This

4:45

is an enormous amount of work and an

4:47

extraordinarily difficult topic and

4:49

as you mentioned let alone device, trauma

4:52

patients, etc. multiple institutions. So entire

4:54

group should be just commended on what

4:58

some sure Herculane amount of effort

5:00

and work and very important results. So

5:02

again congratulations to everyone for that. Before

5:05

we go any further to I will dive into

5:08

the study design aspects and so Nina if you

5:10

will let's talk about some of the key points

5:12

of it and maybe Dr. Brohi can refine

5:15

what we talked about and or highlight certain

5:17

things when it comes to study design. Yeah

5:20

absolutely and I think it's important to highlight

5:22

that this was the pragmatic study design which

5:24

I think is critical especially when this is

5:27

a known device to most trauma surgeons at

5:29

this point and implementation is really

5:31

the question at hand is how we actually roll

5:33

this out and use it. So this

5:35

was a pragmatic rheumatoid randomized control

5:38

trial with the main study

5:40

group and an eligible study participants

5:43

being patients with confirmed or suspected

5:45

life threatening torso hemorrhage thought

5:47

to be amenable to adjunctive treatment with

5:49

a zone 1 or a zone 3

5:52

rubola and the inclusion was really at

5:54

the discretion of the trauma surgeon treating

5:56

this patients. Their primary out

5:58

time was 90 day mortality. but they also

6:00

studied mortality at 3 hours, 6 hours, 24 hours, and

6:02

30 days, as

6:06

well as time to hemorrhage control as

6:08

a procedure, and then blood usage and

6:10

other complications. All

6:12

eligible centers underwent some training beforehand.

6:14

So they underwent either the basic

6:16

endovascular skills for trauma or the

6:19

best course, or the endovascular

6:21

skills for trauma and resuscitative surgery,

6:23

the E-STARRS course, to

6:25

provide a baseline of training prior

6:27

to rolling out this study procedure.

6:30

The study didn't specify which type of

6:32

catheter specifically had to be used, and

6:34

I think that was probably part of

6:36

the pragmatic design, correct me if I'm

6:38

wrong, but basically they,

6:41

again, left the device choice to

6:43

the treating surgeon. They incorporated

6:45

data from 16 separate trauma centers.

6:47

It was an intention to treat

6:49

analysis, and they utilized Bayesian logistical

6:52

regression to interpret their results. Dr.

6:55

Broghead, do you want to add to that in

6:57

terms of design? No, I think that

7:00

was done well summarized. I think the key probably is,

7:02

though, is that the clinician had to

7:04

feel that they might benefit from rubber, and

7:07

at that point, they were randomized to either

7:09

receive it or not. So

7:11

it's not just a blood pressure less

7:13

than 90 or something. There was this

7:16

patient, maybe a rubber candidate, we should

7:18

randomize into the study. And

7:20

very pragmatic, as Nina says. Excellent.

7:23

This study enrolled over five years.

7:25

There were 90 patients in the

7:27

final analysis, and enrollment was stopped

7:30

prematurely because the stopping the rule

7:32

for harm was actually met. This

7:34

resulted in 46 patients in the Raboa

7:36

arm versus 44 patients in the standard care

7:39

loan group. The vast number of

7:41

patients were blunt injuries of 97%, and 23% of these

7:43

patients had pre-hospital CPR. The

7:48

ISS was 41. Those are

7:50

extremely sick patients. And

7:53

furthermore, the groups were evenly matched, but we

7:55

should say that there was a bit more

7:58

hypotension and a bit higher. score

8:00

for the head in the Raboa group. A

8:08

important when it comes to discussion.

8:10

The first is that the time from scene to

8:13

arrival, the median time was

8:15

90 minutes so quite long. Of

8:19

the 46 Raboa patients only

8:21

41% of them had the device

8:24

inserted and inflated. So again

8:26

41% of the patients in the Raboa

8:28

group had the balloon actually up. 37% responded

8:30

to resuscitation while

8:32

Raboa was being performed or prepared

8:35

and therefore did not have balloons

8:37

inflated. 17% of

8:40

patients did not have

8:42

arterial access established and

8:45

4% of patients deteriorated before arterial access

8:47

could be established. The Raboa was deployed

8:49

in zone 1 up in the chest

8:51

in 53% versus zone

8:54

3. They were bifurcation in 47%

8:56

so roughly even there. The

8:59

median ED time or excuse me the median

9:01

rival to balloon inflation time I should say

9:03

was 32 minutes.

9:07

Anina you want to talk a little bit about our primary

9:09

and secondary outcomes? Sure

9:12

so the primary outcome in the study

9:14

reminder was 90-day death or 90-day

9:17

mortality and there were 25

9:19

deaths at 90 days 50% of the Raboa group

9:23

versus 18 deaths or 42%

9:25

in the standard of care. This

9:28

amounted to an odds ratio of

9:30

1.58 for mortality and a posterior

9:32

probability this is a Bayesian term

9:34

that I've recently learned for

9:37

an odds ratio greater than 1 indicating

9:39

increased likelihood of death with Raboa and

9:41

that posterior probability was 86.9% With

9:46

regard to the secondary outcomes all

9:48

deaths or mortality basically across the board

9:50

was increased in that Raboa plus standard

9:52

of care group and more

9:54

were pronounced early in the course so earlier

9:57

deaths were more common in the Raboa group.

10:00

more deaths due to bleeding specifically in the

10:02

Rubella Plus Standard of Care group at amounting

10:04

to about 32% of

10:06

that cohort compared to the Standard of

10:08

Care alone where only 17% of

10:10

patients died because of bleeding. Most

10:13

of those bleeding deaths occurred within the first 24

10:16

hours of study follow-up. 14

10:18

of the Rubella group patients or 30% had a definitive

10:21

hemorrhage control procedure compared with 19 or 43% in

10:23

the Standard of Care alone. So again

10:27

more of those patients who were undergoing

10:29

standard care alone actually eventually underwent

10:31

a hemorrhage control procedure and fewer of them

10:33

eventually died of bleeding and I think that's

10:35

a really important point that we should highlight.

10:38

The median time to hemorrhage control from

10:41

randomization was 83 minutes in

10:43

the Rubella group versus 64 minutes in the

10:45

Standard of Care group. So there was about

10:47

a 19 minute lag in definitive

10:49

hemorrhage control from the time that patients

10:51

were randomized if they got a Rubella.

10:55

Transfusion requirements were similar across those

10:57

groups. The Standard of Care

10:59

alone group had more enhanced

11:01

ICU-free and hospital-free days so they

11:03

tended to get out of the unit faster and

11:05

get out of the hospital faster and there

11:08

were no significant between group differences in

11:10

the number of complications overall which I

11:12

think is also another important point because

11:14

I know I've heard a lot about

11:16

access point complications specifically with regard to

11:18

Rubella use. That was a lot

11:20

Patrick. Yeah, it was a lot. To

11:22

probably go back and try to take this kind

11:24

of point by point, Dr. Brokey, one of the

11:27

things that I was really interested in seeing just

11:29

off the bat to kick it off was

11:31

this 97% blunt trauma

11:33

rate and I'm curious as to whether that's

11:35

standard in the UK and this is just

11:37

again another point toward the gun

11:40

violence epidemic that we have in the United

11:42

States that we frequently see much more penetrating

11:44

trauma or if there were specific differences in

11:46

the institutions that you ended up including in

11:48

this study that they saw just such a

11:50

high blunt trauma rate. So,

11:54

I mean, no,

11:56

it's not typical of UK major trauma centres

11:59

at all actually. So if you look

12:01

at the Cryostat2 trial which was published in the same

12:03

issue, a penetrating rate in Cryostat2

12:05

was like 50% nearly. So

12:08

I think this is about do your

12:10

clinicians felt rubella was appropriate

12:12

for? And

12:14

again, this is conjecture rather than we

12:17

haven't studied this in the gunshot

12:19

abdomen who just needs to get to

12:21

the editor and have his belly open

12:24

versus the complex lung trauma patient with

12:27

a cult hemorrhage from somewhere and maybe

12:29

a head injury as well, possibly pelvic

12:31

issues and you don't know where you're

12:33

going necessarily and then they seem to

12:35

be the ones where rubella was considered

12:37

by other clinicians. They're obviously the ones

12:40

with significantly worse outcomes rather than the

12:42

simple rituals. Yeah,

12:44

and that's seen also in a relatively

12:46

high rate of death. These are lung

12:49

trauma patients with extraordinarily high injury burden and

12:51

so it was 54% in the rubella

12:54

group versus 42% rate of mortality

12:56

in the non-rubella group and

12:58

Nina, I'm glad you brought that up because

13:00

it's extremely important when analyzing this study and

13:02

thinking about your own practice to recognize

13:04

that 97% blood injury

13:07

rate, these are very different types of

13:09

patients than some of our penetrating patients

13:11

and the prior literature in rubella should

13:14

be contextualized in that sense in

13:16

terms of having more patients that were a

13:18

summer from penetrating injury. So

13:21

when we worked on a list of different

13:23

questions and how we can suss this

13:26

out when looking at those results and so the next

13:28

one I have for you is in

13:31

the rubella arm only 41%

13:34

had the device actually inserted and

13:36

inflated. There's a lot of different ways

13:38

to think about why that may have occurred. What

13:40

are your thoughts on it? Yeah, so if you

13:42

look at the breakdown and which you actually

13:45

went through before, so about 40% had the

13:47

balloon. So 19 patients

13:50

essentially of the 46 or say

13:52

randomized rubella had the device inserted

13:54

the balloon up. Then

13:57

About the same number of cases, slightly less.

14:00

It was decided that some point not to

14:02

proceed with back as they actually got better

14:04

to the He madame. It dynamic said it

14:06

had improved. And only I

14:08

think in. Eight. Patients did

14:11

that she I have to write

14:13

or about couldn't be instituted so

14:15

I think that reflects the hatred

14:17

pitcher up to this group of

14:19

patients that these people on how

14:21

difficult it is to understand what

14:23

their trajectory. Is. Going to

14:25

be and therefore to decide who actually.

14:27

As. That exciting when eating on compressed

14:30

will hemorrhage that will benefit from

14:32

ribera who's behind and will respond

14:34

to resuscitation. Who. Was

14:36

got some leading the will stop

14:38

by other means all that can

14:40

be managed sufficiently by ongoing resuscitation

14:42

that they to get to the

14:44

operating room and and undecayed sense

14:46

of control. So.

14:49

So yes, this isn't really a. This.

14:52

Is not a study of in a

14:54

pay silk patient with. Active

14:56

non compress ago. Bleeding.

14:59

Does Ribeira improve? Outcomes

15:01

This is a study of. In

15:03

somebody who looks like that gotten Unc press

15:06

bleeding, who may benefit from a rebel does

15:08

for both improve outcomes and those are quite.

15:10

Significant difference is a thing. Yeah, let's expand

15:13

on that just a little bit because again,

15:15

we talked about the significance of this been

15:17

a pragmatic study design and that's critical. Based.

15:20

On what you just described to us because a lot of

15:22

folks a look at the study and say well. I

15:25

only forty one percent of. Patients.

15:27

In her own rebel group actually got

15:29

robot. Can you explain a little bit

15:31

more about the significance of the real

15:33

world as ability? Of for Obama

15:35

when it comes to. Discussing.

15:37

That statistic. And. Ability

15:40

Different trauma centers moving forward. Yeah.

15:43

I think this speaks to the things

15:45

that were touched on earlier about while

15:47

hesitation in front of him. Is.

15:49

Hypertensive. obviously severely injured,

15:52

Looks. Like they might be bleeding. In.

15:55

That context. Does.

15:57

That patient need. oh with a benefit.

16:00

From. A Multi. Billion.

16:02

Control prior to anything else

16:04

and. As. We know

16:06

is as you very difficult to determine

16:08

the both what's actually going on with

16:10

as patients and that on the subsequent

16:13

trajectory of of those patients and their

16:15

response to resuscitation. So. The

16:17

ribeye which I sense that he says

16:19

at that decision points. If.

16:21

You choose to do a rebel on

16:23

or com a patients in the context

16:25

of. All. The mates trauma censored in

16:28

the Uk give a part of the study. It.

16:30

Doesn't. Work. Now.

16:33

That doesn't necessarily mean to say. What?

16:36

A you could identify the specific

16:38

patients who had i don't know

16:40

actively of a bleeding the wasn't

16:42

gonna respond to standard resuscitation events

16:44

that in that patients. Can

16:46

agree. Lane. One occlusion would

16:48

benefit. But. In the context

16:50

of the clinical entry criteria. That.

16:53

Wasn't the case at these patients. Now

16:55

there are few patients who calls were. Arterial.

16:58

Access and Ribera was have attempted any

17:00

just couldn't be. Island. And they've

17:02

been a lot of. Comments:

17:04

Around the place about well you know it's really

17:06

easy to do or bauer and ever watch the

17:08

outer to access. I don't know who these people

17:11

are. There was a much. Better.

17:13

Than I am, But patients and

17:15

you cargo they'd arrested. They were

17:17

properly hypertensive. I. Found

17:19

the I've struggled to get out hero access

17:22

and The Rebel own exactly that patient that

17:24

near a trained vascular surgeon to be clear

17:26

and I would try Basket and and the

17:28

vascular surgeon you know and I as the

17:31

saw a thing I do all the time.

17:33

It's very very different. Doing.

17:35

It on somebody with about pressure of ninety

17:37

was seventeen and doing on somebody who's got

17:39

no pop. full house at all and you

17:42

can see it any slow. on ultrasounds you

17:44

know that's a very different kettle of fish.

17:47

And clearly. That.

17:49

Induces some so ago they. Which.

17:52

Leads to more bleeding. At least

17:54

that would be that. The.

17:57

assumption reading or much as my reading

17:59

oh really of the UK Rabboa's

18:01

results. Well, and I think that really

18:03

speaks to both the pragmatic nature of this

18:05

trial as well as the intention to treat

18:08

analysis, right? In my master's of epidemiology now

18:10

and we're learning all about how to design

18:12

a trial appropriately and I think

18:14

that's really important and hard to interpret

18:16

if you're not kind of familiar with that type

18:19

of trial design and analysis

18:21

that it doesn't matter if you got the

18:24

intervention of choice, right? It doesn't matter if

18:26

the balloon was up and you got hemorrhage

18:28

control via Rabboa. It matters that you were

18:30

randomized to that arm of the study. I'm

18:33

curious, there was one comment on

18:35

learning curve effects analysis and specifically

18:37

with regard to balloon success or

18:39

successful insertion of the device. I

18:41

wondered, it says that it didn't

18:43

change overall findings but did you see an

18:46

increase in once folks are getting familiar

18:48

with the device and getting arterial access

18:50

early, did you see

18:53

any effects of that or impact of that

18:55

over time of the study? I

18:57

want to add on again, we threw out

18:59

a lot of numbers earlier, so the median

19:01

balloon inflation time as reported was 32 minutes.

19:04

Yes, so the team did some analyses

19:06

excluding the first patient of these to

19:09

see whether there was a learning curve

19:11

effect and obviously some trauma centers were

19:13

already using Rabboa before they went into

19:15

the trial, others came on forward as

19:18

the trial was going on. But of

19:20

course, in each of these

19:22

centers, you've got multiple people taking

19:24

a call on different days, you can't

19:27

guarantee who's going to be doing it

19:29

or when and again, it reflects the

19:33

fact that Rabboa is just not straightforward

19:35

to do and I think one of

19:37

the results of UK Rabboa is that

19:39

it really points to where

19:41

we need to go in terms of if the

19:45

balloon technology is right, then we need

19:47

new and better ways to gain that

19:49

access. Yes, you can put arterial lines

19:51

in earlier but there's actually very difficult

19:53

to know again who these people are who

19:56

are going to benefit from it subsequently And

19:59

every intervention. The delays. Everything.

20:02

Essentially if we talking about twenty minute.

20:04

Delay. Overall, in terms of getting

20:06

to Hammers control, thought Rebar, that's essentially

20:08

the same as putting someone three the

20:10

city scanner. Which. I

20:12

met this a similar so till i

20:14

incurred by. From. The

20:16

decision to do it to actually getting

20:19

to definitive hemorrhage control somewhere along the

20:21

way. twenty minutes is lost. By

20:23

the decisions do about it and we

20:26

know that time is as lights in

20:28

these patients. Leave. Tatchell succeeded in

20:30

video review of Calories as Citizens and the

20:32

name Take Life that I got from typing

20:34

with and is that everyone is slower than

20:37

I think they are right? you think it's

20:39

a simple, a thrilling and artistic and and

20:41

get the balloon outside. It really does

20:43

add said that some time I think everything

20:45

dies. As he mentioned. Yeah, once

20:47

you've got access, the actual idea of

20:50

passing the balloon and blowing the blue

20:52

know takes two minutes. With.

20:55

This there's a big difference he not and

20:57

actually deciding to the ribeira and getting that

20:59

blue know. And. So

21:02

you're You're currently active. you see a lot of

21:04

patience. And again, You. Have been trained

21:06

as a vascular surgeon. What? Are

21:08

some of the problems you see in

21:10

the trauma bay on the ground and

21:12

when it comes to. Get

21:14

in at initial a line had a doctor

21:17

trainees about that and when things are happening

21:19

simultaneously. Exeter. Yeah.

21:21

I things in the context of Ribera

21:24

obviously this to sooner that you can

21:26

get that early access with when the

21:28

patient has a palpable posts. The.

21:30

Better. Oh, and out Saddam is usually used

21:33

to space there from the beginning to be

21:35

used to guide that access. Although we've also

21:37

have patience where we couldn't see anything on

21:39

our son and we've had to go blinds

21:42

using them months. I think it's that I

21:44

different know. If. You

21:46

think? Well, actually. Rebel. Or

21:48

not the way to go? Then.

21:51

Samuel. Arterial access may also not

21:54

be the way to go. In

21:56

these patients, it's not innocuous. It

21:58

does cause problem. later

22:01

on down the line which may

22:03

be large or just a niggle

22:05

and compared to standard

22:07

radial access for arterial

22:10

allowance. I think if you're not doing it for

22:13

a burrow then I'm

22:15

not sure it would be your first

22:18

point of call to do a thermal

22:20

arterial stand. Growing

22:22

access is a skill and a technique that you

22:24

may need to do is a trauma session for

22:27

all sorts of wearing zones. So

22:29

you know it's something you need in your

22:31

armamentarium. Okay let's talk about

22:33

hemorrhage control. 30% of patients in

22:36

the rubbo group and 43% in

22:38

the non-rubbo group at any

22:40

point went on to have a hemorrhage control

22:42

procedure which is

22:45

interesting and at first glance you might think that's

22:47

not very many and so I'd love to hear

22:50

more about your thoughts on that. Yeah I mean

22:52

I think again if you look at let's

22:54

say the rubbo group so a third

22:58

of them more than a third of

23:00

them got better without rubbo and

23:02

so a number of them had stopped bleeding one

23:04

way or the other beforehand.

23:06

We also know that a

23:08

couple of people deteriorated and probably

23:10

died before they could get to

23:14

hemorrhage control and

23:16

then there's another group

23:18

who we know

23:20

receive rubbo and then appear to stop bleeding

23:23

they can have the balloon taken down and

23:25

then they seem to stabilize and then they

23:27

go to scan and

23:29

there's nothing actively bleeding or

23:32

but again if

23:34

somebody's not actively bleeding then

23:36

they might spend more time in the emergency

23:38

bay they don't need to crash into the

23:40

operator. So again this is about well

23:43

this patient looks like they might be bleeding

23:45

and benefit from

23:47

rubbo but actually a good proportion

23:50

of them either weren't

23:52

bleeding had bled then

23:55

It stopped or the amount of

23:57

bleeding reduced during the course, so

23:59

you'd guess. Maybe about that

24:01

low. Thirty percent of the

24:03

patients were actively bleeding. To.

24:06

The point where they needed that is that if it

24:08

is immersed in drop. All. That.

24:11

Died before they got that have which

24:13

was a relatively small I think. To.

24:15

Patients or something don't remember exactly a

24:17

small number of to grip us. Exciting

24:19

when I to before. The. Tend

24:22

to timorous control Ghana. Didn't think

24:24

that the did play any other the

24:26

time in China day. these are undifferentiated.

24:28

Won't li. Injured patients rate. Wonder if

24:31

that a little bit of that was just kind

24:33

of peddling three? then. And. And kia

24:35

point again about. That. Large proportion

24:37

of these decency to get better without

24:39

any intervention really whatsoever in the rebel

24:42

group in particular. And curious

24:44

about that threaten to descended hemorrhage control

24:46

procedure because not only was the proportion

24:48

of higher and then on rebel a

24:50

group but also that time to definitive

24:52

hemorrhage control as longer nineteen minutes your

24:54

to be exact in that. Room.

24:56

At Rebelo Randomized group and I'm curious.

24:58

I hear a lot from Mine Citizen

25:01

about. Taking the second

25:03

you get that balloon out than you need

25:05

to move somewhere else and get definitive hemorrhage

25:07

control. Do you think that played a role

25:09

in that time being longer does it kind

25:11

of. Lol. People entered into feeling like things

25:13

are safe and controlled that that point. And.

25:15

Patch at your and games of all of that

25:17

one either minutes to adjust again. Discovered that the

25:20

remake so quickly earlier. The median

25:22

time to hammers control from the

25:24

point of randomization. Was. Eighty three

25:26

minutes in the rebel group and sixty four minutes.

25:29

And. The Standard Group and Tom Baker's here

25:31

which but that to get. This has prompted

25:33

a lot of discussion amongst ourselves as well.

25:36

So I think to the first point about

25:38

blood pressure gets better people take a for

25:40

off the gas. I think that may well

25:42

have been. An issue

25:45

it in in a while to

25:47

places and we've. We've

25:49

certainly have patience early on. in rubber out

25:51

with the repo trial where the balloon has

25:53

gone up they see to stabilize and than

25:55

somebody has decided to take into the city's

25:57

gonna you know because to see was go.

26:00

on. And so again, I think

26:02

this is about understanding the

26:04

use of RABOA and where it's

26:07

used and also understanding

26:09

the difference between how RABOA

26:11

is used as a exsanguination

26:14

control device versus

26:17

adjunct to hemorrhage management as it seems

26:19

to be in many studies. In

26:22

terms of the timeline, time to definitive

26:24

hemorrhage control, the goal across the UK

26:27

as a standard is an hour from

26:29

arrival. I think time

26:31

to randomization itself is relatively short.

26:35

And again, given that these

26:38

are the blank polytrauma patients, I

26:40

don't think it's far off what

26:42

you would expect across the broad

26:44

spectrum of trauma care. So again,

26:47

I think it reflects real

26:50

world practice. Again, it's only 40

26:52

patients in each arm,

26:55

so you can't draw huge unpleasant conclusions

26:57

from them. But the actual signals are

26:59

about death due to bleeding

27:02

and delayed time to bleeding, coming through

27:04

loud and clear even within that small

27:06

group of patients. Yeah, and I have

27:08

to say that time to hemorrhage control

27:10

is certainly longer than we would hope

27:12

to see, especially in patients this sick

27:14

who required significant pre-hospital transport times. And

27:16

on one hand, you have to remember that

27:18

these are complex patients with blunt, not

27:21

penetrating injuries, and they're often

27:23

more complex. However, 83 minutes

27:25

in the remote group and 64 minutes in

27:27

the non remote group is hard to

27:29

reconcile, especially when these patients are so hypotensive.

27:33

Now, we like to think that

27:35

we are faster than we are, that's for sure.

27:37

And there's some data to suggest that these times

27:40

are in fact consistent with real world practice.

27:43

But I'd like to know if you think this

27:45

contributed to the relatively high mortality rate in these,

27:47

again, very sick patients. I mean,

27:49

if you look at studies like the Harbin study on

27:52

normal apro-emortality and things,

27:55

which is well

27:57

described on both sides of the Atlantic and military

27:59

and civilian as remaining

28:01

very high for this group

28:03

of patients. These

28:05

results are right on the money essentially

28:08

in terms of what the mortality

28:10

would be expected from people with

28:12

an ISS 40, blood pressure less

28:14

than 90 and who are going

28:16

for a laparotomy are requiring significant

28:18

transfusion. It's the same. And

28:20

some centers are clearly using it

28:22

as adjuncts to a bloodless

28:24

field during trauma, a laparotomy or something where

28:27

they are just going in the operating room

28:30

just prior procedure or very

28:32

late in the ED course,

28:34

median systolic of 90 millimeters

28:36

of mercury in some studies.

28:38

These are not those patients. And again, those

28:40

patients will have had a palpable pulse, access

28:43

would have been easier. So

28:45

this is very much

28:47

more what

28:50

Rabbo was originally designed for by the

28:52

told Rasmussen and people a solution to

28:54

exciting when 18 and all compressible. With

28:57

that in mind, how do we interpret this

28:59

study and move it into the next phase?

29:01

I mean, we talked a little bit about

29:04

implementation and how we should be using these

29:06

devices and how a lot of this has

29:08

already happened prior to having randomized

29:10

data to guide us. So now that we

29:12

do have some randomized data, how

29:14

do you think this these results of the study

29:16

should be interpreted and moved

29:18

into actual practice? Yeah, I

29:21

think everyone has to look at it

29:23

within the context of their own setting,

29:25

their own geography, their own practice and

29:28

see how they apply to what they

29:30

do. I don't think I can

29:32

speak for rural America or Norway

29:34

or anything like that. I think

29:36

from the UK context, what's

29:39

clear is that Rabbo as

29:41

it is currently designed

29:44

and delivered, probably

29:47

does not have a routine place

29:49

within the major trauma sensor. I

29:51

think having said that, there

29:54

are patients where it has proved of

29:56

utility, you know, groin blowout, part

29:58

of hemorrhage type patients. non-trauma

30:01

like patients. So I don't think there's any

30:03

kind of blanket ban on it but

30:05

I think people need to be more

30:07

specific about when they use

30:09

it and also understand the

30:12

time consequence of deploying

30:14

it. And I think if you are

30:16

going to carry on using Robeiro,

30:19

then you absolutely need to

30:21

understand your timelines without it

30:23

and to study each case

30:26

and exactly those timelines and how

30:28

it's deployed and when it is

30:30

deployed. I think the other point

30:33

is that we still need a

30:35

solution for non-compressible tools over the hundreds and

30:37

it was designed for

30:41

not for within trauma center care

30:43

but for far forward and pre-hospital

30:46

care and eukarybore

30:49

does not preclude its use in

30:51

those settings where transport

30:53

times may be well in excess

30:56

of that 20-minute window and

30:58

so you may be losing

31:00

little. Obviously then with longer transport

31:02

times you need to have

31:05

a solution for prolonged ischemic times

31:07

and so partial Robeiro, interventional Robeiro,

31:09

those sorts of things

31:11

coming to play and more studies needed.

31:15

But I think it may well push

31:17

Robeiro back to the place where it

31:19

was originally intended which is in those

31:21

deployed settings. Yeah and that's interesting for

31:23

shereobold back to where it was originally

31:25

intended which as this study shows is

31:28

not in major UK trauma centers for

31:30

use on sick blunt trauma

31:32

patients and to me really

31:34

one of the paradoxes of Robeiro is that trauma

31:36

centers that are best equipped to use it in

31:38

terms of volume and skill and

31:41

careful evaluation of outcomes with subsequent

31:43

iteration as needed.

31:46

These are the same centers who

31:48

are also best equipped for and

31:51

have the most practice in rapid

31:53

hemorrhage control without riboa. So

31:55

the question is which centers if any should riboa

31:57

be used in and to your second point Really

32:01

the intensive area of research should probably

32:03

be focused on adjunctive hemorrhage control in

32:06

this far-forward environment. I definitely agree with that and

32:08

you know I want to thank you and really

32:10

commend you and the rest of the team on

32:13

phenomenal work. This data was sorely needed and allowed

32:15

us to have this conversation and so with that

32:17

do you have any additional take-home points?

32:20

I think the thing for me that

32:22

the UK Boer trial does above everything

32:24

else is really bring

32:27

home the fact that time

32:30

is critical for bleeding trauma patients. I don't

32:33

think there's any better expression of it than

32:36

the UK Boer trial actually. You

32:38

can do all the propensity matching

32:40

and time series analysis of observational

32:42

data you want but there is

32:44

a critical difference

32:46

here of 20 minutes only in

32:49

these patients that has led to

32:51

substantially higher bleeding, rates of

32:53

death of bleeding and I think

32:55

that applies not just to Raboa but to

32:57

everything we do. Decisions to go to CT

33:00

or not, decisions to do investigations,

33:02

decisions to add in an extra line

33:04

before you go to the operating room.

33:07

You know how quickly you can get triangulation

33:10

products into patients or get answers back. I

33:12

think this really in

33:15

my view is much bigger than

33:17

Raboa and refocuses demand for these

33:20

patients on how critical time

33:22

is and how much faster we really need

33:24

to move even when we think we're moving

33:26

fast in these patients. That

33:30

being said this is obviously generated a bunch

33:32

of questions even just among the two of

33:34

us Patrick and I but I'm curious what

33:36

your next questions are for Raboa and for

33:38

this incredible group of

33:40

facilities and researchers that you've

33:43

been a part of. Yeah

33:46

so we're having some discussions

33:49

at multiple levels. We've got big

33:51

dissemination program in track that will

33:54

involve all the UK major trauma

33:56

centers and again a discussion about

33:58

what is the place for Raboa. and

34:00

for us and where we go next, we have

34:02

a big pre-hospital

34:05

program using partial program pre-hospital led

34:07

by Robbie Lendrum. We hope we'll

34:09

be able to report on that

34:11

very shortly for the first case

34:13

series. And then looking

34:15

at a scheming adjunct that may

34:18

support the scheme to allow those little

34:20

transport times. So, you know, there's still

34:22

a lot to do in this place.

34:24

It's not a yes, no,

34:26

no question. And maybe

34:28

there are alternatives, the non-compressible hemorrhage

34:31

as well that we need to explore further.

34:35

Well again, we appreciate your time and for sharing your

34:37

expertise with us. Thanks for coming on Behind the Knife

34:39

and to all the listeners, dominate the day. Be

34:42

sure to check out our website at www.behindtheknife.org

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35:00

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