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New treatment option for Traumatic Brain Injuries
Official title Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
ClinicalTrials.gov ID: NCT05115929
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)
You likely can't join if
- 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...
- Intracranial injury mandating craniotomy/craniectomy in itself
- Intraabdominal injury mandating laparotomy in itself
The study team makes the final eligibility decision.
Where it's taking place
- Clamart, France
- Koblenz, Germany
- Munich, Germany
- Ulm, Germany
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clamart, France; Koblenz, Germany; Munich, Germany; Ulm, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.