A Randomized double blind Placebo controlled trial of Vitamin D in subjects with acute severe traumatic brain injury.

PGIMER Dr Ram Manohar Lohia Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Male or female patients age between 16 to 65 years.
•2.Weight from 45 to 135 kg
•3.Sustained a closed head trauma within 8 hours of injury before screening and enteral nutrition started in 24 hours after admission before initiation of study drug.
•4.TBI diagnosed by history, clinical examination and/ or radiological imaging.
•5.Post-resuscitation GCS score between 4 to 12.
•6.TBI screened patient whose baseline Vita D level above 56 ng/ml.
•7.At least one reactive pupil.
•8.Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshallâ??s CT Classification).
•9.Indication for ICP monitoring.

•1.Life expectancy of less than 24 hours as determined by the investigator.
•2.Prolonged and/or uncorrectable hypoxia (pa02 <60mmHg) or hypotension (systolic blood pressure <90 mmHg) upon admission.
•3.Any spinal cord injury.
•4.Pregnancy
•5.Patients with penetrating head injury.
•6.Patients having upper active gastrointestinal bleed.
•7.Bilaterally fixed dilated pupils at the time of randomization.
•8.Coma suspected to be primarily due to other causes (eg. Alcohol).
•9.Pure epidural hematoma.
•10.Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome.
•11.Severe cardiac or hemodynamic instability after resuscitation.
•12.Known treatment with another investigational drug therapy or procedure within 30 days of injury.
•13.TBI patient who has abnormal baseline Serum calcium (more than 1.0 mg/dL) and urine calcium level (more than 0.21).
•14.A history of allergic reaction to vitamin D and related drugs or any of the components of the infusion.
•15.Patients with severe anoxic intracerebral damage or brain death.
•19.Unknown patients.

发起方

PGIMER Dr Ram Manohar Lohia Hospital