Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock

NCT ID: NCT05941572

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-28

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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Non-compressible Torso Hemorrhage Trauma Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Honnef

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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35-345 ex 22/23

Identifier Type: -

Identifier Source: org_study_id

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