Clinical trial NCT06312436: The AT-REBOA Target Trial
Official title: The Effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Trauma Patients With Uncontrolled Haemorrhage: Study Protocol for a Target Trial and Its Emulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Shock, Traumatic
Cardiac Arrest Due to Trauma
Polytrauma
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target trial seeks to enrol patients in the trauma room who are thought to be at imminent risk of dying from acute blood loss due to non-compressible torso or lower body haemorrhage.

Brief summary: Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control.

In the past years, studies have tried to evaluate the benefit for this method with conflicting results. The previous UK-REBOA trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. A major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with REBOA.

The aim of this study is to evaluate the effectiveness of REBOA in a setting with already experienced providers.


Eligibility criteria: Inclusion criteria:

* aged, or believed to be aged, 16 years or above
* confirmed or suspected life-threatening torso or lower body trauma
* thought to benefit from trauma resuscitation with REBOA

Exclusion criteria:

* penetrating chest trauma
* known or suspected pregnancy at presentation
* prehospital thoracotomy
* severe burns injuries.

Primary outcomes:
measure: 30-day in-hospital mortality
timeFrame: 30 days
Secondary outcomes:
measure: 3-hour mortality
timeFrame: 3 hours
measure: 6-hour mortality
timeFrame: 6 hours
measure: 24-hour mortality
timeFrame: 24 hours
measure: 90-day mortality
timeFrame: 90 days
measure: Intensive Care Unit length of stay
timeFrame: within 6 months
measure: Hospital length of stay
timeFrame: within 6 months
measure: Blood product use
timeFrame: 48 hours
measure: Use of whole body computed tomography
timeFrame: during resuscitation care phase within 3 hours
measure: damage control procedure performed
timeFrame: during resuscitation phase within 3 hours
measure: Time to damage control procedure
timeFrame: during resuscitation phase within 3 hours
measure: Rate of complications
timeFrame: within 6 months
measure: Cause of death
timeFrame: within 6 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Medical Centre Graz
state: Styria
city: Vienna
country: Austria
facility: Center for Medical Data Science
Study officials:
References:
citation: Stannard A, Eliason JL, Rasmussen TE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011 Dec;71(6):1869-72. doi: 10.1097/TA.0b013e31823fe90c. No abstract available.
citation: Jansen JO, Hudson J, Cochran C, MacLennan G, Lendrum R, Sadek S, Gillies K, Cotton S, Kennedy C, Boyers D, Ferry G, Lawrie L, Nath M, Wileman S, Forrest M, Brohi K, Harris T, Lecky F, Moran C, Morrison JJ, Norrie J, Paterson A, Tai N, Welch N, Campbell MK; UK-REBOA Study Group; Aylwin C, Bew D, Brooks A, Chinery J, Cowlam T, Frith D, George A, Hudson A, Johnstone P, Mahmood A, Novak A, O'Meara M, Reid S, Sattout A, Smith C, Stansfield T, Thompson J. Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1862-1871. doi: 10.1001/jama.2023.20850.