Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Technical University of Munich
100 participants
Oct 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria6
- 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
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Interventions
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.
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.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05115929