| CTRI Number |
CTRI/2018/04/013280 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
management of severe head injury patients |
|
Scientific Title of Study
|
“ Intracranial pressure guided management among severe traumatic brain injury patients with no surgically evacuable mass lesion;comparision between decompressive craniectomy with maximal medical management - A randomized controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anil Chandra |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Neurosurgey, KGMU,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839123415 |
| Fax |
|
| Email |
neurochandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manohar S |
| Designation |
Senior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Neurosurgey, KGMU,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9686111449 |
| Fax |
|
| Email |
drmanuhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof B K Ojha |
| Designation |
prof and head of neurosurgery department, kgmu |
| Affiliation |
King Georges Medical University |
| Address |
Department of neurosurgey, KGMU,Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415108077 |
| Fax |
|
| Email |
bkojha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT OF NEUROSURGERY , KING GEORGES MEDICAL UNIVERSITY, , LUCKNOW , UTTAR PRADESH , INDIA |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University |
| Address |
Dept of Neurosurgery, King Georges Medical university, Lucknow , India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manohar S |
king Georges medical college |
trauma centre. department of neurosurgery.king Georges medical college
Lucknow
UTTAR PRADESH |
09686111449
drmanuhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
severe head injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BARBITURATES |
PATIENTS WITH REFRACTORY ICP SUBJECTED TO BARBITURATES COMA.3MG/KG BOLUS GIVEN THEN 10 TO 20 MG/KG LOADING DOSE GIVEN OVER ONE HOUR. 3 TO 5 MG/KG/HR MAINTENANCE DOSE GIVEN AND CONTINUED UNTIL ICP IS CONTROLLED AND MAINTAINED FOE 48 TO 72 HOURS. WEANING IS DONE BY DECREASING THE THE DOSE BY HALF EVERY 12 HOURS. BP MONITORING DONE AND MAINTAIN SYSTOLIC BP MORE THAN 100MMHG. |
| Intervention |
deompressive craniectomy and barbiturates |
DECOMPRESSION OF BRAIN DONE BY LARGE HEMICRANIECTOMY WITH DUROPLATY AND PLACE THE BONE IN ANT ABDOMINAL WALL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Traumatic brain injury
1) CT scan with no evidence of surgically evacuable lesion
2) GCS ≤ 8 on admission after initial resuscitation
3) Admission within 24 hours of injury
4) Closed head trauma
|
|
| ExclusionCriteria |
| Details |
1) GCS of 3 with bilateral fixed and dilated pupil.
2) Severe coagulopathy that is not correctable.
3) Surgically evacuable lesion on CT.
4) Previous Craniectomy.
5) Associated spinal cord injury.
6) Refusal by care takers to become a part of study.
7) Pregnancy.
8) Refusal by care takers after randomization to accept the group the patient is alloted.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glasgow coma scale |
Glasgow coma scale 7 days and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hospital stay. survival , decrease ICP |
at discharge or death |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/01/2016 |
| Date of Study Completion (India) |
20/09/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
head injury is the most common cause for death in young generation all over the world. even with the best available management prognosis is bad. in our study we insert extraventricular drain in severe head injury patients and measure intra cranial pressure(ICP). even with so many studies results are not clear. mode of management is not clear. in our study icp monitoring avoided unnecessary imtervention in 30% of our patienrs. it found in our study suegical management is better than medical management |