Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury… (NCT02716532) | Clinical Trial Compass
CompletedNot Applicable
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
Switzerland17 participantsStarted 2016-04
Plain-language summary
This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH).
This clinical study is an open-label, non-randomized, single-center, exploratory metabolic study.
The primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Comatose patients (defined by an initial Glasgow Coma Scale (GCS) \< 9) following sTBI or aSAH.
* Female or male, aged \>18.
* Abnormal head CT-Scan (contusions, hematoma).
* Intracranial monitoring with CMD, \[PbtO2\] and \[ICP\] probes as part of standard of care.
* Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests.
* Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study
Exclusion Criteria:
* Signs of brain death or expected brain death within 48h.
* Pregnancy.
* Hemodynamic instability (circulatory shock, requiring vasopressors).
* Renal or liver insufficiency .
* Chronic intestinal disease.
* Patients requiring parenteral nutrition .
* Currently participating or having participated in another clinical trial during the month preceding the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support