Resuscitative Endovascular Balloon Occlusion of the Aorta... | NCT05941572

Studies
Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock

NCT05941572

Sponsor

Medical University of Graz

Status

Withdrawn

Last Update Posted

May 9, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Non-compressible Torso Hemorrhage
Trauma Injury

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

change of study plan

Expanded Access Info

Start Date

Jun 28, 2023Actual

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Nov 1, 2023Estimated

First Submitted Date

Jul 4, 2023

First Submission Date that Met QC Criteria

Jul 4, 2023

First Posted Date

Jul 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2025

Last Update Posted Date

May 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Trauma patients with non-compressible torso hemorrhage and REBOA placement in the initial resuscitation phase.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel Honnef	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz	Styria	8010	Austria

Condition Browse Module

MeSH Terms

ID	Term
D000081084	Accidental Injuries
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

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