Clinical trial NCT05941572: Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock
Official title: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Patients With Major Trauma and Uncontrolled Haemorrhagic Shock: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-compressible Torso Hemorrhage
Trauma Injury
Keywords: uncontrollable hemorrhage
trauma
ballon occlusion of the aorta
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Trauma patients with non-compressible torso hemorrhage and REBOA placement in the initial resuscitation phase.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Occurrence of complications
timeFrame: 30 days
measure: Blood products
timeFrame: initial resuscitation phase (day one after admission)
Secondary outcomes:
measure: hemodynamic improvement (blood pressure)
timeFrame: initial resuscitation phase (day one after admission)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Gabriel Honnef
role: PRINCIPAL_INVESTIGATOR
References: