Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Recruiting
N/A
Interventional Study
Traumatic Brain Injuries
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Technical University of Munich · Other
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age between 18 and 65 years
2. Traumatic Brain Injury with abnormal CT scan
3. Invasive ICP monitoring in place
4. ICP \>25 mmHg for 1-12h after conventional therapies step I and step II (see Trial flow chart)
Exclusion Criteria:
1. Bilateral fixed and dilated pupil
2. Limi…
Contacts