| CTRI Number |
CTRI/2025/04/084780 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
ROLE OF COAGULATION STUDIES IN HEAD INJURY |
|
Scientific Title of Study
|
A study on the Role of Rotational Thromboelastography in management of Traumatic Brain Injuries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshan B Y |
| Designation |
Senior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department Of Neurosurgery
Goa Medical College
Bambolim
Goa
North Goa GOA 403202 India |
| Phone |
9740443884 |
| Fax |
|
| Email |
bydarshan1994@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DARSHAN B Y |
| Designation |
SENIOR RESIDENT |
| Affiliation |
GOA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF NEUROSURGERY
GOA MEDICAL COLLEGE
BAMBOLIM
GOA 403202
GOA 403202 India |
| Phone |
9740443884 |
| Fax |
|
| Email |
bydarshan1994@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Darshan B Y |
| Designation |
Senior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department Of Neurosurgery
Goa Medical College
Bambolim
Goa
GOA 403202 India |
| Phone |
9740443884 |
| Fax |
|
| Email |
bydarshan1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College, Bambolim , Goa 403202 |
|
|
Primary Sponsor
|
| Name |
Goa Medical College |
| Address |
Bambolim , Goa
403202 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Darshan B Y |
Goa Medical College |
Department Of Neurosurgery
Goa Medical College
Bambolim North Goa GOA |
9740443884
bydarshan1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , GOA MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Isolated traumatic brain injury
acute period less than fourty eight hours
craniotomy to treat traumatic brain injury
|
|
| ExclusionCriteria |
| Details |
Polytrauma
Known hematological disease in patients
Use of Anticoagulants and antiplatelets in patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reasonable implementation of ROTEM in Isolated TBI patients undergoing craniotomy
|
72 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine the effectiveness of rotational thromboelastometry in peri -operative coagulation management |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Traumatic brain injury is one of the most common cause of death and disability in road traffic accidents. Damage to cerebral parenchyma leads to coagulopathy due to increased tissue factor release, disseminated intravascular coagulation, quantitative and qualitative platelet deficits and activation of protein C pathways. Standard coagulation tests are used to identify coagulopathy but they generally provide inadequate information on complete hemostasis. To overcome this, viscoelastic studies like Rotational thromboelastometry are being implemented in traumatic brain injuries which provide real time information regarding coagulation, right from initiation to fibrinolysis, which inturn help in goal-directed coagulopathic correction.Targeted coagulopathic correction could lead to better outcome.Viscoelastic studies in trauma ,cardiac and liver surgeries have proved to decrease perioperative bleeding and use of blood products with targeted therapy. This study will help in evaluating the usefulness of Rotational thromboelastometry in patients undergoing craniotomy in isolated traumatic brain injuries |