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

NCT04145271 | Completed

• 1 other identifier: 271728
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 4

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

Conditions

Emergencies; Trauma Injury; Trauma, Multiple

Outcome Measures

Primary Outcomes (2)

• 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

  1 day

• 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.

  1 day

Secondary Outcomes (16)

• • Incidence of Zone I balloon positioning in the ED

  1 Days

• • Incidence of pre-hospital balloon migration

  1 Day

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

  1 Day

• • Method of achieving Partial REBOA

  1 Day

• • Incidence of failed femoral arterial access

  1 Day

Interventions

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (4)

Royal London Hospital

London, E1 1FR, United Kingdom

Location

London HEMS

London, E1, United Kingdom

Location

St. Georges Hospital

London, SW17 0QT, United Kingdom

Location

St.Marys Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38985496 DERIVED

• 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.

  PMID: 36864520 DERIVED

MeSH Terms

Conditions

Emergencies; Accidental Injuries; Multiple Trauma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: October 30, 2019
• Study Start: June 27, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)