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CTRI Number  CTRI/2025/09/094625 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two different doses of a medicine which reduces blood loss (tranexamic acid), on its effect on total blood loss and blood product transfusion requirements in patients undergoing surgery for removing tumors located at base of brain 
Scientific Title of Study   Comparing two doses of intraoperative tranexamic acid on blood loss, blood and blood product transfusion requirements in patients undergoing complex skull base tumour resection: A non-inferiority randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreekumar M R 
Designation  DM Resident 
Affiliation  Christian Medical College 
Address  Department of Neuroanaesthesia, CMC Vellore, Ranipet campus, Kilminnal Village, Ranipet District

Vellore
TAMIL NADU
632517
India 
Phone  7012528932  
Fax    
Email  drsreekumar1993@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ramamani Mariappan 
Designation  Professor and Head of Department 
Affiliation  Christian Medical College 
Address  Department of Neuroanaesthesia, CMC Vellore, Ranipet campus, Kilminnal Village, Ranipet District

Vellore
TAMIL NADU
632517
India 
Phone  9443753184  
Fax    
Email  ramamani@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sreekumar M R 
Designation  DM Resident 
Affiliation  Christian Medical College 
Address  Department of Neuroanaesthesia, CMC Vellore, Ranipet campus, Kilminnal Village, Ranipet District

Vellore
TAMIL NADU
632517
India 
Phone  7012528932  
Fax    
Email  drsreekumar1993@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College Vellore, Ranipet campus, Kilminnal Village, Ranipet District, Tamil Nadu-632517, India 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Christian Medical College, Vellore, Ranipet campus, Kilminnal Village, Ranipet District, Tamil Nadu- 632517, India 
Type of Sponsor  Private 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 
Dr Sreekumar M R  Christian Medical College  Neurosurgery Operation Theatres, Department of Neurosciences, CMC Vellore, Ranipet Campus, Kilminnal village, Ranipet District, Tamil Nadu-632517, India
Vellore
TAMIL NADU 
07012528932

drsreekumar1993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CHRISTIAN MEDICAL COLLEGE VELLORE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intermediate Dose Tranexamic Acid  Tranexamic Acid administration at 20 mg/kg bolus followed by 2mg/kg/hr infusion from incision time till start of dural closure 
Intervention  Low Dose Tranexamic Acid   Tranexamic acid administration at 10 mg/kg bolus followed by 1mg/kg/hr infusion from incision time till start of dural closure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA grade I-III, undergoing craniotomies for excision of complex skull base tumours 
 
ExclusionCriteria 
Details  Extremes of age less than 18 and more than 70 years, ASA IV, Patients with known allergy to the drug, Patients with a past history of Deep Vein Thrombosis, CVT or pulmonary embolism, Stroke any increased risk for thrombosis, Patients with IHD on a coronary stent, post CABG, low EF, Patients with motor deficit, Polycythaemia – Haemoglobin more than 17 gms, Pre-operative Haemoglobin less than 8 gms, Pre-operative transfusion less than 1 week, Patients with CKD with creatinine more than 1.5 mgs, Patients with uncontrolled seizures, Pre-existing coagulopathy, Bleeding disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood loss and blood, blood product transfusion requirements   Incision time to 6 hours after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Serum tranexamic acid concentration  One hour  
Rotational thromboelastometry parameters  One hour  
Incidence of complications associated with TXA administration, such as seizure & Deep venous thrombosis (DVT) or pulmonary embolism (PE)   One week 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   Phase 4 
Date of First Enrollment (India)   01/10/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Skull base tumour resection is associated with major blood loss and an increased risk for perioperative allogenic transfusion. Perioperative blood and blood product transfusions are associated with increased morbidity and mortality. Various perioperative blood-conservation strategies are routinely used to reduce the allogenic blood transfusion in patients undergoing complex brain tumour surgery. TXA is one of the crucial components of perioperative blood conservation strategies.

Tranexamic acid (TXA), is a synthetic lysine analogue that prevents activation of plasminogen into plasmin. TXA functions as an antifibrinolytic by preventing the plasmin-induced fibrinolysis and stabilising the existing clot. TXA has been shown to reduce bleeding in various surgical conditions, including neurosurgery.  Among the neurosurgical procedures, its use has been well documented for reducing the blood loss and blood transfusion in traumatic brain injury, major spine surgery, craniosynostosis correction surgery and meningioma surgeries. But its use in other elective craniotomies, such as complex skull base tumours, is understudied.

Based on a thorough literature search, to our knowledge, to date, there is only one retrospective study which looked at the effect of TXA on blood loss and blood transfusion requirement in patients undergoing skull base tumour excision. Hence, we wanted to do an RCT in all adult patients undergoing complex skull base tumours and study the efficacy of TXA on reducing the blood loss during surgery and blood transfusion during and within 6 hours of transfusion .

All eligible patients will be approached and recruited into the study after obtaining informed consent. Then they will be randomized to either Group A (20mg/kg bolus f/b 2 mg/kg/hr infusion, intermediate dose) or Group B (10mg/kg bolus f/b 1 mg/kg/hr infusion, low-dose) according to the randomisation sequence. TXA infusion will be continued till dural closure. Standard anaesthesia protocol will be followed for induction, intubation and maintenance. Intraoperative fluid administration will be guided by Pulse pressure variation, haemodynamics (MAP and HR), and urine output.  Blood loss will be calculated in a standardised manner. All the necessary pre- and intraoperative data will be collected. Blood and blood products will be transfused based on the definite transfusion trigger. Serum samples for TXA level and ROTEM(Modified EXTEM) will be taken 1 hour after stopping the TXA infusion. At the end of surgery, patients will be extubated (after meeting the extubation criteria) or ventilated, depending on the intraoperative course at the discretion of the anaesthesiologist or surgeon. Postoperatively, patients will be followed up till discharge the necessary data will be calculated and documented in the data sheet.

 
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