An open label, non randomized, uncontrolled, bio interventional, single centric, pilot study in Traumatic Brain Injury
- Registration Number
- CTRI/2010/091/000436
- Lead Sponsor
- ADVANCED NEURO-SCIENCE ALLIES PVT. LTD#560, Bhargavi, 9th "A" Main, Indiranagar, Bangalore-560 038Karnataka (INDIA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion of patients for therapy will be under the investigator's discretion. However the following criteria will be considered.
1.More than 18 years old on the day of injury
2.Hospital admission Glasgow coma score between 5 and 8
3.Significant Traumatic brainstem
4.Altered Sensorium >1 month
5.Severe cognitive impairment
6.less than one month post-injury
7. Willing to return for follow-ups through out the duration of the study.
Exclusion of patients from therapy will be under the investigator?s discretion. However the following criteria will be considered
1.On ventilatory support
2.Previous brain injury
3.Significant clinical evidence of infection
4.Evidence of raised ICT clinical / radiological or by monitor
5.Renal disease or altered renal function as defined by serum creatinine > 1.5 mg/dL at admission
6.Hepatic disease or altered liver function as defined by SGPT > 150 U/L, and/or T. bilirubin > 2 mg/dL at admission
7. Cancer
8.Hemodynamic instability at the time of consent defined as ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normals for age
9.Uncorrected coagulopathy at the time of consent
10.Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and/or PaO2:FIO2 ratio < 250 associated with the mechanism or injury
11.Solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging
12.any otherinjury as diagnosed by CT or MR imaging or by clinical findings.
13.Persistent hypoxia defined as SaO2 < 94% for > 30 minutes
14.Positive urine pregnancy test ( in case of females)
15.Participation in any other intervention study
16.Unwillingness to return for follow-up visits
17.Positivity for HIV, HBV, HCV,VDRL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1At 1, 3, 6 ,9 and 12 months after discharge, patients will have follow-up examinations to assess their clinical status and to review their current medication. <br>2Glasgow coma scale, <br>3PULSES profile <br>4Disability rating scale. <br>5Safety and tolerability, assessed by adverse events<br>6Quality of life<br>7Neurological events such as seizures, change in Glasgow coma scale (GCS), cerebral vascular accident (CVA)] <br>8infectious morbidity <br>9secondary organ injuryTimepoint: 3,6,9,12 months
- Secondary Outcome Measures
Name Time Method Secondary Outcome will be the change in the baseline and improvement (if any) in the quality of life of the patient.Timepoint: 3,6,9,12 months