Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

August 31, 2026

Conditions
Traumatic Brain Injuries
Interventions
PROCEDURE

Decompressive Laparotomy

As described in the study protocol a long midline laparotomy is performed and open abdomen therapy using negative pressure dressings initiated to lower abdominal pressure and thereby improve venous return from the brain to lower intracranial pressure.

PROCEDURE

Decompressive Craniectomy

As described in the study protocol a sufficiently sized hemi-craniectomy is performed and the skin closed over the bony defect to allow cerebral swelling and thereby lower intracranial pressure.

Trial Locations (4)

56072

NOT_YET_RECRUITING

Bundeswehrzentralkrankenhaus Koblenz, Koblenz

81675

RECRUITING

Department of Neurosurgery - Klinikum rechts der Isar, Munich

89081

RECRUITING

Bundeswehrkrankenhaus Ulm, Ulm

92140

NOT_YET_RECRUITING

HIA Percy, Clamart

All Listed Sponsors
collaborator

Federal Ministry of Defence (Germany)

UNKNOWN

collaborator

Bundesministerium der Verteidigung

UNKNOWN

lead

Technical University of Munich

OTHER