| 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
|
|
|
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
|
|
|
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. |