The AT-REBOA Target Trial

Hemorrhage Clinical Trial

— AT-REBOA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06312436
• Other study ID #: AT-REBOA
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: March 2024

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: March 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Multiple Trauma
• Polytrauma
• Shock, Traumatic

Intervention

Procedure:
• Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)
Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival.

Locations

Country	Name	City	State
Austria	University Medical Centre Graz	Graz	Styria
Austria	Center for Medical Data Science	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day in-hospital mortality		30 days
Secondary	3-hour mortality		3 hours
Secondary	6-hour mortality		6 hours
Secondary	24-hour mortality		24 hours
Secondary	90-day mortality		90 days
Secondary	Intensive Care Unit length of stay	days	within 6 months
Secondary	Hospital length of stay	days	within 6 months
Secondary	Blood product use	amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates	48 hours
Secondary	Use of whole body computed tomography		during resuscitation care phase within 3 hours
Secondary	damage control procedure performed	operation or angioembolisation	during resuscitation phase within 3 hours
Secondary	Time to damage control procedure	operation or angioembolisation	during resuscitation phase within 3 hours
Secondary	Rate of complications	acute kidney injury °III, use of renal replacement therapy, arterial thrombosis or embolism, limb ischaemia, vascular injury, compartment syndrome requiring fasciotomy	within 6 months
Secondary	Cause of death		within 6 months