Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock

Trauma Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941572
• Other study ID #: 35-345 ex 22/23
• Status: Recruiting
• Start date: June 28, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: September 2023
• Source: Medical University of Graz
• Contact: Gabriel Honnef, MD
• Phone: 004331638581283
• Email: gabriel.honnef[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Shock, Hemorrhagic
• Trauma Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	all cause mortality	30 days
Primary	Occurrence of complications	Complications due to ballon occlusion of the aorta	30 days
Primary	Blood products	Used blood products	initial resuscitation phase (day one after admission)
Secondary	hemodynamic improvement (blood pressure)	hemodynamic improvement after ballon occlusion of the aorta (blood pressure)	initial resuscitation phase (day one after admission)