Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Age between 18 and 65 years
• Traumatic Brain Injury with abnormal CT scan
• Invasive ICP monitoring in place
• ICP \>25 mmHg for 1-12h after conventional therapies step I and step II (see Trial flow chart)
Locations
Other Locations
France
HIA Percy
NOT_YET_RECRUITING
Clamart
Germany
Bundeswehrzentralkrankenhaus Koblenz
NOT_YET_RECRUITING
Koblenz
Department of Neurosurgery - Klinikum rechts der Isar
RECRUITING
Munich
Bundeswehrkrankenhaus Ulm
RECRUITING
Ulm
Contact Information
Primary
Sandro Krieg, PhD, MBA
sandro.krieg@tum.de
+498941407605
Backup
Benny Kölbel, MD, MBA
bennykoelbel@bundeswehr.org
+49731171033119
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Treatments
Active_comparator: Decompressive Craniectomy Group
participants with severe TBI randomly assigned as described in the study protocol
Active_comparator: Decompressive Laparotomy Group
participants with severe TBI randomly assigned as described in the study protocol
Related Therapeutic Areas
Sponsors
Collaborators: Federal Ministry of Defence (Germany), Bundesministerium der Verteidigung
Leads: Technical University of Munich