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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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