Hemorrhage Clinical Trial
— AT-REBOAOfficial 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
Verified date | March 2024 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Austria | University Medical Centre Graz | Graz | Styria |
Austria | Center for Medical Data Science | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
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
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 |
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