Clinical trial NCT04145271: Pre-Hospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Injured Patients With Exsanguinating Sub-diaphragmatic Haemorrhage
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Trauma Injury
Trauma, Multiple
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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). 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Zone 1 REBOA
timeFrame: 1 day
measure: Partial REBOA (P-REBOA)
timeFrame: 1 day
Secondary outcomes:
measure: • Incidence of Zone I balloon positioning in the ED
timeFrame: 1 Days
measure: • Incidence of pre-hospital balloon migration
timeFrame: 1 Day
measure: • Incidence of balloon repositioning (proximal or distal) pre or in-hospital.
timeFrame: 1 Day
measure: • Method of achieving Partial REBOA
timeFrame: 1 Day
measure: • Incidence of failed femoral arterial access
timeFrame: 1 Day
measure: • Time elapsed from balloon inflation to the institution or recognition of P-REBOA.
timeFrame: 1 Day
measure: • Incidence of balloon reinflation or the requirement for additional balloon volume, post institution or recognition of P-REBOA.
timeFrame: 1 Day
measure: • Total duration of REBOA (inflation to final deflation).
timeFrame: 1 Day
measure: • Systolic blood pressure response to institution of REBOA
timeFrame: 1 day
measure: • Incidence of pre-hospital cardiac arrest
timeFrame: 1 day
measure: • Incidence of pre-hospital, ED, or operating theatre resuscitative thoracotomy (RT).
timeFrame: 1 Day
measure: • Mortality rate - Pre-hospital, one hour, 3 hours, 24 hours, 30 and 90 days.
timeFrame: 90 days.
measure: • Causes of death (in-hospital and pre-hospital) of patients who received Pre-Hospital REBOA or did not following a failed attempt.
timeFrame: 1 year
measure: • Survival to hospital discharge.
timeFrame: 90 Days
measure: • Length of critical care and hospital stay.
timeFrame: 90 Days
measure: • 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:
timeFrame: 90 Days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: London HEMS
city: London
country: United Kingdom
facility: St. Georges Hospital
city: London
country: United Kingdom
facility: St.Marys Hospital
Study officials:
References: