| CTRI Number |
CTRI/2021/12/038456 [Registered on: 06/12/2021] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Transcranial Doppler guided management of severe traumatic brain injury in trauma intensive care unit |
|
Scientific Title of Study
|
Transcranial Doppler-Guided Management Of Severe Traumatic Brain Injury Admitted In Trauma Intensive Care Unit: A Prospective, Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bisman Jeet Kaur Khurana |
| Designation |
senior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department Of Anesthesia and Intensive Care, 4th floor Block B , Nehru Building ,PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9811911223 |
| Fax |
|
| Email |
khurana.bisman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Bhatia |
| Designation |
Additional professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department Of Anesthesia and Intensive Care, 4th floor Block B , Nehru Building ,PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Bhatia |
| Designation |
Additional professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department Of Anesthesia and Intensive Care, 4th floor Block B , Nehru Building ,PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
SECTOR 12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| BISMAN JEET KAUR KHURANA |
Department of Anesthesia and Intensive Care,POST GRADUATE INSTITUTE OF MEDICAL SCIENCES |
Department Of Anesthesia and Intensive Care
Fourth Floor ,
A Block Nehru Hospital ,
PGIMER,
Madhya Marg SECTOR 12,CHANDIGARH
Chandigarh
CHANDIGARH |
9811911223
khurana.bisman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PGIMER , CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S060||Concussion, (2) ICD-10 Condition: S061||Traumatic cerebral edema, (3) ICD-10 Condition: S062||Diffuse traumatic brain injury, (4) ICD-10 Condition: S063||Focal traumatic brain injury, (5) ICD-10 Condition: S064||Epidural hemorrhage, (6) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (7) ICD-10 Condition: S068||Other specified intracranial injuries, (8) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (9) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
clinical radiological examination |
ICU management of patients in initial 72 hours will be guided by clinical and radiological examination only. NO transcranial doppler will be performed |
| Intervention |
transcranial doppler |
ICU management of patients in initial 72 hours will be guided by Transcranial doppler measured parameters in addition to clinical and radiological examination |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients 18-65 years of age, with severe TBI (Glasgow Coma Scale 3-8) 25 at the time of admission to Intensive Care Unit
2.Admitted to Trauma Intensive Care Unit (ICU) for mechanical ventilatory support and conservative management.
3.Admitted to Trauma ICU within 48 hours of injury
|
|
| ExclusionCriteria |
| Details |
1. Pregnant females and pediatric patients
2. Relatives unwilling to give consent for participation in the study
3. Patients admitted to hospital >24 of injury
4. Glasgow Coma Scale (GCS) of 3 with bilateral fixed and dilated pupils
5. Non-survivable injury like decapitation or hemicorporectomy.
• Inability to obtain ultrasound window for performing Transcranial doppler (TCD)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional status and orientation at 3 months following injury, assessed with the use of the Extended Glasgow Outcome Scale [GOS-E](annexure I) and the Disability Rating Scale [DRS](annexure II). |
3 months post injury |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| . Total ventilator days |
end of icu stay |
| Brain-specific treatments received |
end of icu stay |
| Total length of ICU stay |
end of icu stay |
| Incidence of neurological worsening |
end of icu stay |
| Frequency of neurosurgical procedures |
end of icu stay |
| Adverse events/complications, if any |
end of icu stay |
| Time to hospital discharge |
end of hospital stay |
| GCS at the end of hospital stay |
end of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2021 |
| Date of Study Completion (India) |
31/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Traumatic brain injury (TBI) is the leading cause of morbidity, mortality and disability across the globe and contributes to almost 40% of all injury-related deaths.The disabilities associated with TBI significantly increase the disease as well as the socio-economic burden.Though studies in the past evaluating the diagnostic and/or prognostic role of TCD in TBI, however most of these studies were observational cohort studies. Data from randomized, controlled trials of TCD monitoring in the management of patients with severe TBI are lacking. We thus plan to conduct this study with the aim of determining whether the information derived from TCD-guided neuromonitoring of patients with severe TBI as an add on to the clinical and radiological examination will improve patient outcomes. Our hypothesis is that ICU management protocol based on the use of TCD monitoring would reduce the ICU stay, thus reducing morbidity and improve patient outcome. |