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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06312436
Other study ID # AT-REBOA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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