Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Patients With Major Trauma and Uncontrolled Haemorrhagic Shock: a Retrospective Analysis

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05941572

Enrollment

Registered

2023-07-12

Start date

2023-06-28

Completion date

2023-11-01

Last updated

2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-compressible Torso Hemorrhage, Trauma Injury

Keywords

uncontrollable hemorrhage, trauma, ballon occlusion of the aorta

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
hemodynamic improvement (blood pressure)	initial resuscitation phase (day one after admission)	hemodynamic improvement after ballon occlusion of the aorta (blood pressure)

Countries

Austria

Outcome results