To study the role of vitamin D in improving the clinical outcome in patients with Traumatic Brain Injury in India
- Conditions
- Health Condition 1: S063- Focal traumatic brain injury
- Registration Number
- CTRI/2019/05/019259
- Lead Sponsor
- PGIMER Dr Ram Manohar Lohia Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcomes of the study will be mortality and Extended Glasgow outcome score at discharge, 6 months and 1 year after discharge in the follow up. The Extended Glasgow Outcome (GOS-E) score contains following levels of outcome: good recovery, moderate disability, severe disability, vegetative survival and Death.Timepoint: one year
- Secondary Outcome Measures
Name Time Method The secondary efficacy endpoints will be the functional outcome as assessed by Functional Independence Measure (FIM) score. It consists two subscales, FIM Motor (FIM-M) and FIM Cognitive (FIM-COG). The FIM-M consists of 13 items of motor function and movement (score ranging from 13-91) and the FIM-COG 5 items regard the processing of information, interaction with others and communication (score ranging from 5-35); thereby giving a total score range of 18-126.Timepoint: one years