Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Launched by TECHNICAL UNIVERSITY OF MUNICH · Nov 8, 2021
Trial Information
Current as of September 07, 2025
Recruiting
Keywords
ClinConnect Summary
The SCALPEL trial is studying two different surgical treatments to help reduce dangerously high pressure inside the brain, which can happen after a traumatic brain injury (TBI). The goal is to find out whether a procedure called decompressive craniectomy (removing a part of the skull) or decompressive laparotomy (opening the abdominal cavity) is better for improving patients' long-term recovery. Researchers will assess how well patients function 12 months after the treatment using a scale that measures their overall recovery.
To participate in this trial, individuals must be between 18 and 65 years old, have a TBI confirmed by a CT scan, and need monitoring for high intracranial pressure that remains elevated after standard treatments. However, those with certain severe conditions, such as fixed pupils or major injuries requiring immediate surgery, cannot join. Participants can expect to receive one of the two surgical treatments, and their progress will be monitored closely over the next year to see how well they recover. This study aims to find the best way to help patients who experience high intracranial pressure after a brain injury.
Gender
ALL
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. Limitation of therapies by the team due to poor prognosis
- • 3. Withdrawal of consent
- • 4. 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
- • 5. Intracranial injury mandating craniotomy/craniectomy in itself
- • 6. Intraabdominal injury mandating laparotomy in itself
About Technical University Of Munich
The Technical University of Munich (TUM) is a leading research institution in Germany, renowned for its commitment to excellence in education, innovation, and technology transfer. With a strong emphasis on interdisciplinary collaboration, TUM fosters advancements in various fields, including medicine and life sciences. The university actively engages in clinical research, aiming to translate scientific discoveries into practical applications that improve patient outcomes. Through its state-of-the-art facilities and a network of partnerships with hospitals and industry, TUM is dedicated to conducting rigorous clinical trials that adhere to the highest ethical standards and contribute significantly to the advancement of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ulm, , Germany
Clamart, , France
Koblenz, , Germany
Munich, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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