BridgeMD
New treatment option for Traumatic Brain Injury
Official title Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.
ClinicalTrials.gov ID: NCT07092423
What this study is testing
- What it's testing
- Study Objective This clinical trial primarily aims to investigate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI) and to evaluate its impact on clinical outcomes. The safety profile of SEN will also be assessed.
- 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 75
You may be able to join if
- Aged 18-75 years;
- Clinically diagnosed with closed traumatic brain injury;
- Glasgow Coma Scale (GCS) score ≤ 8;
- Ability to initiate enteral nutrition within 48 hours post-injury;
- Expected need for enteral nutrition support ≥3 days based on clinical assessment (Nutritional Risk Screening 2002 [NRS2002] score ≥3).
You likely can't join if
- GCS=3 with bilateral fixed and dilated pupils;
- Hemodynamic instability or respiratory failure: mean arterial pressure \ 45 mmHg, or lactate \>5 mmol/l;
- Contraindications to both nasogastric and nasojejunal tube placement, or inability to complete tube placement within 48 hours of onset;
- Contraindications to enteral nutrition therapy or semi-recumbent positioning;
- Pre-existing intellectual disability or physical disability affecting outcome assessment;
- Gastrointestinal abnormalities likely to affect gastrointestinal function, such as short bowel syndrome (defined as total small bowel length ≤122...
See the full eligibility criteria
- Aged 18-75 years;
- Clinically diagnosed with closed traumatic brain injury;
- Glasgow Coma Scale (GCS) score ≤ 8;
- Ability to initiate enteral nutrition within 48 hours post-injury;
- Expected need for enteral nutrition support ≥3 days based on clinical assessment (Nutritional Risk Screening 2002 [NRS2002] score ≥3).
- GCS=3 with bilateral fixed and dilated pupils;
- Hemodynamic instability or respiratory failure: mean arterial pressure \ 45 mmHg, or lactate \>5 mmol/l;
- Contraindications to both nasogastric and nasojejunal tube placement, or inability to complete tube placement within 48 hours of onset;
- Contraindications to enteral nutrition therapy or semi-recumbent positioning;
- Pre-existing intellectual disability or physical disability affecting outcome assessment;
- Gastrointestinal abnormalities likely to affect gastrointestinal function, such as short bowel syndrome (defined as total small bowel length ≤122 cm), ulcerative colitis, Crohn's disease, or any form of ostomy;
- Body mass index (BMI) \<18kg/m2;
- Concomitant abdominal injury or extracranial injury with AIS score \>3 in any region;
- Presence of malignancy, severe cardiac insufficiency (ejection fraction \<50%), severe hepatic failure (Child-Pugh score ≥7), or severe renal failure (glomerular filtration rate ≤30 mL/min or serum creatinine ≥4mg/dL)...
- Concurrent severe disease with expected survival ≤14 days;
- Pregnancy, within 30 days postpartum, or breastfeeding;
- Refusal of treatment or receipt of palliative care;
- Patient or family declines informed consent;
- Current participation in another treatment clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Compensation & support
Compensation mentioned.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. 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.