| CTRI Number |
CTRI/2024/05/067553 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare giving tranexamic acid all at once versus giving it in two parts to people having brain tumour surgery to see which way works better for stopping bleeding |
|
Scientific Title of Study
|
Comparison of the effect of tranexamic acid bolus dose with bolus followed by infusion on perioperative blood loss in adult patients undergoing brain tumour 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 |
Utkarsh Rathi |
| Designation |
Post graduate resident doctor |
| Affiliation |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Department of anaesthesia and intensive care
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
South
DELHI
110029
India |
| Phone |
9810310159 |
| Fax |
|
| Email |
utkarshstudy1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Panwar |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Faculty Room
Department of anaesthesia and intensive care
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
South
DELHI
110029
India |
| Phone |
9810310159 |
| Fax |
|
| Email |
drmkumath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Utkarsh Rathi |
| Designation |
Post graduate resident docto |
| Affiliation |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Department of anaesthesia and intensive care
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
South
DELHI
110029
India |
| Phone |
9810310159 |
| Fax |
|
| Email |
utkarshstudy1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi India |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Office of the H.O.D.
Department of anaesthesiology and intensive care
Vardhaman Mahavir Medical College And Safdarjung Hospital New Delhi
|
| 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 |
| Dr Utkarsh Rathi |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anaesthesiology and intensive care
Vardhaman Mahavir Medical College and Safdarjung Hospital New Delhi
South
DELHI |
9810310159
utkarshstudy1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vardhman Mahavir Medical and Safdarjung Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified, (2) ICD-10 Condition: D320||Benign neoplasm of cerebral meninges, (3) ICD-10 Condition: C717||Malignant neoplasm of brain stem, (4) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (5) ICD-10 Condition: C716||Malignant neoplasm of cerebellum, (6) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, (7) ICD-10 Condition: C715||Malignant neoplasm of cerebral ventricle, (8) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (9) ICD-10 Condition: C709||Malignant neoplasm of meninges, unspecified, (10) ICD-10 Condition: C714||Malignant neoplasm of occipital lobe, (11) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (12) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (13) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tranexamic Acid |
Injection Tranexamic Acid 15 mg/kg upto 1 gram bolus dose followed by continuous infusion of tranexamic acid at a rate of 1 mg/kg/hour |
| Intervention |
Tranexamic Acid |
Injection Tranexamic Acid 15 mg/kg upto 1 gram over 20 mins as bolus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18 to 65 years undergoing brain tumour surgery
2. American Society of Anaesthesiologists (ASA) grade I and II only |
|
| ExclusionCriteria |
| Details |
1. Patients who have a history of allergic reaction to tranexamic acid
2. Patients having previous documented history of thromboembolic disease
3. Patients who have documented coagulopathies diagnosed before surgery
4. Patients with documented hepatic or renal dysfunction |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The amount of blood loss during surgery in millilitres
|
At the end of surgery i.e. skin closure has finished |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood loss during surgery
|
Every hourly starting from time of incision till completion of surgery i.e. skin closure completed |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="3"
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
|
The antifibrinolytic effect of tranexamic acid is well established and studies support its role in cases of neurosurgery to reduce intraoperative blood loss. However, few studies have attempted to evaluate the efficacy of intravenous bolus as compared to continuous intravenous infusion of tranexamic acid in patients undergoing neurosurgery. Keeping these observation in mind, this study is being undertaken to evaluate the efficacy of intravenous bolus dose of tranexamic acid with intravenous bolus followed by continuous infusion of tranexamic acid in neurosurgery patients undergoing brain tumour surgery. |