None listed
Conditions
Interventions
Intervention1: bilateral precoronal burr hole: 4 million cells/ kg body weight
Control Intervention1: NIL: Not applicable
Sponsors
ADVANCED NEURO-SCIENCE ALLIES PVT. LTD
#560, Bhargavi, 9th "A" Main, Indiranagar,
Bangalore-560 038
Karnataka (INDIA)
Eligibility
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 At 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. 2 Glasgow coma scale, 3 PULSES profile 4 Disability rating scale. 5 Safety and tolerability, assessed by adverse events 6 Quality of life 7 Neurological events such as seizures, change in Glasgow coma scale (GCS), cerebral vascular accident (CVA)] 8 infectious morbidity 9 secondary organ injuryTimepoint: 3,6,9,12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMrs. Vijayalakshmi
Outcome results
None listed