Comparing craniectomy and laparotomy for treating high intracranial pressure from traumatic brain injuries
Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
This study tests whether a surgery to remove part of the skull or a surgery to open the abdomen is better at lowering pressure in the brain for adults with traumatic brain injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 4 sites (Clamart and 3 other locations) |
| Trial ID | NCT05115929 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of decompressive craniectomy versus decompressive laparotomy in lowering intracranial pressure (ICP) in patients with traumatic brain injuries (TBI). It aims to determine which surgical intervention leads to better long-term functional outcomes, measured by the Glasgow Outcome Scale after 12 months. The study includes patients aged 18 to 65 with abnormal CT scans and invasive ICP monitoring. By comparing these two approaches, the trial seeks to identify a safer and more effective treatment for managing high ICP in TBI patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with traumatic brain injuries and elevated ICP who have undergone invasive monitoring.
Not a fit: Patients with severe pre-existing disabilities or those requiring immediate craniotomy or laparotomy for other injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes for patients suffering from traumatic brain injuries with elevated intracranial pressure.
How similar studies have performed: Previous studies have shown varying outcomes for craniectomy, but the use of laparotomy for this purpose is less commonly tested, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clamart and 3 other locations
- HIA Percy — Clamart, France (Not_yet_recruiting)
- Bundeswehrzentralkrankenhaus Koblenz — Koblenz, Germany (Not_yet_recruiting)
- Department of Neurosurgery - Klinikum rechts der Isar — Munich, Germany (Recruiting)
- Bundeswehrkrankenhaus Ulm — Ulm, Germany (Recruiting)
Study contacts
- Study coordinator: Sandro Krieg, PhD, MBA
- Email: sandro.krieg@tum.de
- Phone: +498941407605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.