| CTRI Number |
CTRI/2024/09/073231 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Administration of Tranexamic Acid can affect the Intra-operative blood loss in Brain Tumor resection surgery |
|
Scientific Title of Study
|
Effect of Tranexamic Acid on Intra-Operative Blood Loss in Brain Tumor Resection Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushkar Ranjan |
| Designation |
Professor |
| Affiliation |
heritage institute of medical sciences |
| Address |
HOD
Dept. of Anaesthesiology
heritage institute of medical sciences varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9415986684 |
| Fax |
|
| Email |
pushkarranjanbhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Singh Heyar |
| Designation |
junior resident |
| Affiliation |
heritage institute of medical sciences |
| Address |
Dept. of Anaesthesiology
heritage institute of medical sciences varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9988777074 |
| Fax |
|
| Email |
abhinavheyar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepshikha |
| Designation |
assistant professor |
| Affiliation |
heritage institute of medical sciences |
| Address |
Dept of Anaesthesiology
Heritage institute of medical sciences varanai
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
7405848568 |
| Fax |
|
| Email |
stunningshikha87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Heritage Institute of Medical Sciences Grand Trunk Road Bhadwar Varanasi 221311 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Heritage Institute of Medical Sciences |
| Address |
Grand Trunk Road Bhadwar
Varanasi 221311 Uttar Pradesh
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 Abhinav Singh Heyar |
Heritage institute of medical sciences |
OT COMPLEX 4th Floor
Department of Anaesthesiology
Varanasi
UTTAR PRADESH |
9988777074
abhinavheyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee heritage institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect Of Tranexamic Acid on intra-operative blood loss in Brain tumor resection Surgery |
Patient’s in the study group will be administered Tranexamic acid (TXA) intravenously – 10 mg/ kg body weight over 10 minutes after induction followed by continuation of maintenance infusion at the rate of 1 mg /kg/ hr intra-operatively till skin closure
Patient’s in the control group will be administered the same volume of saline per kg body weight ( the same as TXA)
At the end of surgery, blood loss assessment will be done by counting gauges , mops used and volume in suction bowl.
|
| Comparator Agent |
Effect Of Tranexamic Acid on intra-operative blood loss in Brain tumor resection Surgery |
Patient’s in the study group will be administered Tranexamic acid (TXA) intravenously – 10 mg/ kg body weight over 10 minutes after induction followed by continuation of maintenance infusion at the rate of 1 mg /kg/ hr intra-operatively till skin closure Patient’s in the control group will be administered the same volume of saline per kg body weight ( the same as TXA) At the end of surgery, blood loss assessment will be done by counting gauges , mops used and volume in suction bowl. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with brain tumor who will undergo tumor resection surgery after admission
Age group 18 – 65 years
Patient without any history of coagulopathy
|
|
| ExclusionCriteria |
| Details |
Patient having hypersensitivity to Tranexamic
acid
Patients with known contraindications to
antifibrinolytic agents
Patients with thromboembolic events.
Patients with abnormal liver function.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of Tranexamic acid (TXA) on the intra-operative blood loss during tumor resection surgery.
|
Base line post induction and continuous intra operative Blood Loss assessment at 30 minute interval
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 2 |
|
Date of First Enrollment (India)
|
12/09/2024 |
| 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="6"
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
|
•Intracranial tumor excision can be associated with major blood loss and require transfusion of large volumes of blood and blood products . •The Intra-operative blood loss is in turn directly related to the post-operative morbidity and mortality •Tranexamic Acid (TXA) is a synthetic derivative of the amino acid lysine that acts as an antifibrinolytic, is largely used to reduce the blood loss . •Administration of Tranexamic acid (TXA) , has resulted in survival benefits in Traumatic Brain Injury (TBI) patients ,by reducing blood loss as per recent studies In this study , we aim to study the effect of Tranexamic acid (TXA) in reduction of intra-operative blood loss. •Aim is to study the effect of Tranexamic acid(TXA) on Intra –operative Blood Loss during Brain Tumor Resection Surgery
|