Clinical Trial

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

Study acronym: SCALPEL
Recruiting
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Record status
This record was last updated May 16, 2023 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-11-08.
Status change: Not Yet Recruiting → Recruiting 2023-05-14
Trial Details
NCT Number NCT05115929
Lead Sponsor Technical University of Munich
Collaborators: Federal Ministry of Defence (Germany), Bundesministerium der Verteidigung
Conditions Traumatic Brain Injuries
Enrollment 100 participants
Start Date 2022-10-01
Primary Completion 2025-12 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2023-05-16