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NCT Number: NCT04145271

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

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

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Key information

Conditions

Emergencies Accidental Injuries Disease Attributes Multiple Trauma Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma Injury Trauma, Multiple Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London HEMS, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • 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)

Exclusion criteria

-

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

Treatment and study plan

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

Primary outcomes

  1. Zone 1 REBOA

    Time frame: 1 day

    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

  2. Partial REBOA (P-REBOA)

    Time frame: 1 day

    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.

Secondary outcomes

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

    Time frame: 1 Days

    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.

  2. • Incidence of pre-hospital balloon migration

    Time frame: 1 Day

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

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

    Time frame: 1 Day

    Repostioned in aorta for clinical reason

  4. • Method of achieving Partial REBOA

    Time frame: 1 Day

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

  5. • Incidence of failed femoral arterial access

    Time frame: 1 Day

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

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

    Time frame: 1 Day

    Temporal

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

    Time frame: 1 Day

    For clinical reason.

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

    Time frame: 1 Day

    Temporal

  9. • Systolic blood pressure response to institution of REBOA

    Time frame: 1 day

    Physiological

  10. • Incidence of pre-hospital cardiac arrest

    Time frame: 1 day

    Pre and post REBOA, absent carotid or central pulse.

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

    Time frame: 1 Day

    RT

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

    Time frame: 90 days.

    Mortality

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

    Time frame: 1 year

    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).

  14. • Survival to hospital discharge.

    Time frame: 90 Days

    Survival

  15. • Length of critical care and hospital stay.

    Time frame: 90 Days

    Temporal

  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:

    Time frame: 90 Days

    • 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).

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Acronym: P-PRO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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