Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock

Withdrawn

• Conditions: Trauma Injury; Non-compressible Torso Hemorrhage

• Registration Number: NCT05941572
• Lead Sponsor: Medical University of Graz

Brief Summary

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal to stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.

The investigators are planning to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.

Detailed Description

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.

The investigators plan to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.

Investigators will search for patients who had a REBOA catheter placed in the study period in the clinical documentation system (openMEDOCS) and the database of the German trauma registry. Documentation will include hemodynamic parameters, transfused blood products, complications, basic demographics and mortality up to thirty days after REBOA placement.

The investigators will then try to find patients with similar trauma mechanism and severity of trauma in the German trauma registry and match them with their REBOA patients.

Study Timeline

• Study Start: 2023-06-28
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Status Verified: 2023-09
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient with non-compressible torso hemorrhage following major trauma with REBOA placement
• age>18 years
• REBOA placement during the initial resuscitation

Exclusion Criteria

• age<18 years
• missing data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	all cause mortality
Occurrence of complications	30 days	Complications due to ballon occlusion of the aorta
Blood products	initial resuscitation phase (day one after admission)	Used blood products

Secondary Outcome Measures

Name	Time	Method
hemodynamic improvement (blood pressure)	initial resuscitation phase (day one after admission)	hemodynamic improvement after ballon occlusion of the aorta (blood pressure)

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria