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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peptamen AF | Other | over 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peptamen AF | Dietary Supplement | Each patient will receive Peptamen AF throughout the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support | Over 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients | After at least 2 consecutive days of stable enteral nutrition | |
| Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Cuénoud, PhD | Nestec SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care Medicine CHUV | Lausanne | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Over 7 days (not necessarily at stable EN). |
| As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients | Over 7 days |
| Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care | Over 7 days |
| To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients | Over 7 days |
| Evaluation of the time to reach two days of stable nutrition in all patients | Over 7 days |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |