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EmergenciesP-PRONCT04145271

Pre-Hospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Injured Patients With Exsanguinating Sub-diaphragmatic Haemorrhage

An observational study of Emergencies and Trauma Injury, run by Barts & The London NHS Trust at 4 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is unknown whether this evolved strategy (Pre-Hospital Zone I P-REBOA) is feasible and with an acceptable safety profile. This study will address this question, therefore informing the design of a prospective multicentre exploratory cohort study followed by a pilot/feasibility multicenter RCT (IDEAL 2B). Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Emergencies, Trauma Injury, Trauma, Multiple
What is being tested?
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)
Type of treatment
Medical device
How many people
10 participants
Where
4 sitesUnited Kingdom
Study dates
27 Jun 2020to 31 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 8 Patients cannulated for REBOA (+ all other patients meeting the inclusion criteria during the study period where there was a failed attempt at femoral arterial access).

Who may be able to join

  • Adult trauma patients (aged, or believed to be aged 16 years or older) attended by LAA;
  • assessed to have exsanguinating sub-diaphragmatic haemorrhage and imminent risk of hypovolaemic cardiac arrest, or recent hypovolaemic cardiac arrest;
  • which is thought to be amenable to treatment with Zone I REBOA;
  • and an attempt is made at femoral arterial access (percutaneous access or open surgical approach to insert 8Fr REBOA access sheath)

Who cannot join

  • Age < 16 years
  • Injuries deemed clinically unsurvivable
  • Known or visible advanced pregnancy

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

  • Royal London Hospital

    London, E1 1FR

  • London HEMS

    London, E1

  • St. Georges Hospital

    London, SW17 0QT

  • St.Marys Hospital

    London, W2 1NY

Other trials in United Kingdom

About this study

Official title: Pre-Hospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Injured Patients With Exsanguinating Sub-diaphragmatic Haemorrhage (P-PRO-Study)

It is unknown whether this evolved strategy (Pre-Hospital Zone I P-REBOA) is feasible and with an acceptable safety profile. This study will address this question, therefore informing the design of a prospective multicentre exploratory cohort study followed by a pilot/feasibility multicenter RCT (IDEAL 2B). The IDEAL Framework is an internationally recognised standard, that describes the stages through which interventional therapy innovation normally passes, the characteristics of each stage and the study design types recommended for each

Read the detailed description

Haemorrhage (bleeding) is the most common cause of preventable death after injury and is responsible for approximately one-third of trauma deaths (of which between 16-29% of such deaths are thought to be preventable).

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a minimally invasive damage control procedure for life-threatening abdominal and/or pelvic haemorrhage. It involves temporary occlusion of the aorta with an endovascular balloon, providing proximal control to the site of vascular injury whilst supporting cerebral and myocardial perfusion.

Emergency Department (ED) use of REBOA appears to be feasible and associated with improved outcomes. However, bleeding trauma patients die quickly and it's evident that the peak death rate from haemorrhage occurs within 30 minutes of injury. This is well before the majority of patients can reach hospital, it's therefore likely this resuscitation strategy may have greatest benefit for patients when used in the pre-hospital environment.

We have demonstrated that Pre-Hospital Zone III REBOA (distal aortic occlusion) for exsanguinating pelvic haemorrhage is a feasible resuscitation strategy that significantly improves blood pressure and may reduce the risk of hypovolaemic cardiac arrest and early death due to exsanguination.

To evolve this resuscitation strategy, it is important to establish whether it can be delivered in patients with more proximal haemorrhage in the abdomen (Zone I REBOA). However, this development may be associated with increased risk of harm due to the visceral ischaemia that is created. The use of a technique called Partial REBOA (P-REBOA) may offer a solution by mitigating the ischaemia/reperfusion injury created.

It is unknown whether this evolved strategy (Zone I P-REBOA) is feasible in the pre-hospital setting. This study therefore aims to establish via an Observational Cohort of eight adult trauma patients whether Zone I P-REBOA can be achieved in pre-hospital resuscitation of adult trauma patients with exsanguiunating sub-diaphragmatic haemorrhage at risk of imminent hypovolaemic cardiac arrest or recent hypovolaemic cardiac arrest.

Being tested
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)
Medical subject headings
Emergencies, Accidental Injuries, Multiple Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)Device

    Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a minimally invasive damage control procedure for life-threatening abdominal and/or pelvic haemorrhage. It involves temporary occlusion of the aorta with an endovascular balloon, providing proximal control to the site of vascular injury whilst supporting cerebral and myocardial perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Zone 1 REBOA

    The proportion of patients where Pre-Hospital Zone 1 REBOA is achieved, defined as:

    • Balloon insertion depth between 35 - 55 cm
    • Proximal arterial blood pressure transduced
    • Balloon inflation

    Measured: 1 day

  2. Partial REBOA (P-REBOA)

    The proportion of Pre-Hospital Zone 1 REBOA patients where P-REBOA is achieved, defined as:

    • Evidence of an increase in distal mean arterial pressure (MAP) of at least 5mm - 10mmHg above post inflation baseline;
    • and/or a return of distal pulsatility;
    • or distal pulsatility never absent post initial balloon inflation.

    Measured: 1 day

Secondary outcomes (16)

  1. • Incidence of Zone I balloon positioning in the ED

    On routinely performed plain film chest X-Ray. Defined as balloon positioned between T4 - L1 and/or distal to carina, proximal to diaphragm) or on CT.

    Measured: 1 Days

  2. • Incidence of pre-hospital balloon migration

    (>2cm from the recorded insertion depth, reported by the pre-hospital clinical team

    Measured: 1 Day

  3. • Incidence of balloon repositioning (proximal or distal) pre or in-hospital.

    Repostioned in aorta for clinical reason

    Measured: 1 Day

  4. • Method of achieving Partial REBOA

    Balloon deflation, spontaneous, or straight to P-REBOA.

    Measured: 1 Day

  5. • Incidence of failed femoral arterial access

    Inability to successfully cannulate the CFA percutaneously or via an open approach.

    Measured: 1 Day

  6. • Time elapsed from balloon inflation to the institution or recognition of P-REBOA.

    Temporal

    Measured: 1 Day

  7. • Incidence of balloon reinflation or the requirement for additional balloon volume, post institution or recognition of P-REBOA.

    For clinical reason.

    Measured: 1 Day

  8. • Total duration of REBOA (inflation to final deflation).

    Temporal

    Measured: 1 Day

  9. • Systolic blood pressure response to institution of REBOA

    Physiological

    Measured: 1 day

  10. • Incidence of pre-hospital cardiac arrest

    Pre and post REBOA, absent carotid or central pulse.

    Measured: 1 day

  11. • Incidence of pre-hospital, ED, or operating theatre resuscitative thoracotomy (RT).

    RT

    Measured: 1 Day

  12. • Mortality rate - Pre-hospital, one hour, 3 hours, 24 hours, 30 and 90 days.

    Mortality

    Measured: 90 days.

  13. • Causes of death (in-hospital and pre-hospital) of patients who received Pre-Hospital REBOA or did not following a failed attempt.

    This will be determined by the SMG following review of all the routinely available clinical information (CT scan results, operative findings and post-mortem findings).

    Measured: 1 year

  14. • Survival to hospital discharge.

    Survival

    Measured: 90 Days

  15. • Length of critical care and hospital stay.

    Temporal

    Measured: 90 Days

  16. • Incidence of all adverse events related to patient injury, resulting critical illness and treatment as well as femoral cannulation, REBOA catheter insertion and/or the anticipated effects of aortic occlusion:

    • Distal arterial thrombus formation requiring intervention
    • Vascular trauma (related to primary injury or intervention)
    • Surgical repair femoral arterial cannulation site (patch angioplasty)
    • Arterial bypass surgery
    • Cannulation site infection requiring surgical intervention
    • Extremity ischaemia requiring fasciotomies
    • Amputation (primary)
    • Amputation (secondary)
    • Acute renal failure (KDIGO Criteria Stage 3)
    • Requirement for renal replacement therapy (RRT)
    • Acute intestinal ischaemia (Evidence of gut necrosis at laparotomy or findings on CT scanning consistent with gut ischaemia in the context of elevated blood lactate).
    • Multiple Organ Dysfunction Syndrome (MODS, 2 or more organ system failure) including severity of MODS (Sequential Organ Failure Assessment, SOFA Score).

    Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start27 Jun 2020
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145271
Sponsor's protocol ID
271728
Acronym
P-PRO
Status last verified
May 2022
First submitted
4 Sep 2019
Last updated
9 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lendrum RA, Perkins Z, Marsden M, Cochran C, Davenport R, Chege F, Fitzpatrick-Swallow V, Greenhalgh R, Wohlgemut JM, Henry CL, Singer B, Grier G, Davies G, Bunker N, Nevin D, Christian M, Campbell MK, Tai N, Johnson A, Jansen JO, Sadek S, Brohi K. Prehospital Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Exsanguinating Subdiaphragmatic Hemorrhage. JAMA Surg. 2024 Sep 1;159(9):998-1007. doi: 10.1001/jamasurg.2024.2254.

    PubMed 38985496

  • Lawrie L, Duncan EM, Lendrum R, Lebrec V, Gillies K. Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation. Trials. 2023 Mar 2;24(1):157. doi: 10.1186/s13063-023-07184-5.

    PubMed 36864520

Questions about this trial

What is this clinical trial studying?

An observational study of Emergencies and Trauma Injury, run by Barts & The London NHS Trust at 4 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Zone 1 REBOA (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04145271, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.

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