Actively Recruiting
Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Led by Technical University of Munich · Updated on 2023-05-16
100
Participants Needed
4
Research Sites
200 weeks
Total Duration
On this page
Sponsors
T
Technical University of Munich
Lead Sponsor
F
Federal Ministry of Defence (Germany)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Traumatic brain injury with abnormal CT scan
- Invasive intracranial pressure (ICP) monitoring in place
- ICP above 25 mmHg for 1 to 12 hours after conventional therapies (step I and step II)
You will not qualify if you...
- Bilateral fixed and dilated pupils
- Therapy limitation due to poor prognosis
- Withdrawal of consent
- Severe pre-existing physical or mental disability or co-morbidity
- Intracranial injury requiring craniotomy/craniectomy on its own
- Intraabdominal injury requiring laparotomy on its own
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
HIA Percy
Clamart, France, 92140
Not Yet Recruiting
2
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, Germany, 56072
Not Yet Recruiting
3
Department of Neurosurgery - Klinikum rechts der Isar
Munich, Germany, 81675
Actively Recruiting
4
Bundeswehrkrankenhaus Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
S
Sandro Krieg, PhD, MBA
CONTACT
B
Benny Kölbel, MD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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