RecruitingNot Applicable

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

France, Germany100 participantsStarted 2022-10-01

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. Bilateral fixed and dilated pupil
✕. Limitation of therapies by the team due to poor prognosis
✕. Withdrawal of consent
✕. Severe pre-existing physical or mental disability or co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury
✕. Intracranial injury mandating craniotomy/craniectomy in itself
✕. Intraabdominal injury mandating laparotomy in itself

What they're measuring

Functional outcome measured by the extended Glasgow Outcome Scale (GOS-E)

Timeframe: 12 months post-injury

Trial details

NCT IDNCT05115929

SponsorTechnical University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Sandro Krieg, PhD, MBA

+498941407605 sandro.krieg@tum.de

View on ClinicalTrials.gov More Traumatic Brain Injuries trials