| CTRI Number |
CTRI/2024/06/069240 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Role of tranexamic acid in reducing perioperative blood loss in abdominal oncosurgeries in group of patients aged between 25-75years. |
|
Scientific Title of Study
|
To compare the doses of tranexamic acid for maximum reduction in perioperative blood loss in abdominal oncosurgeries( A Randomized 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 |
Shristi Shikha |
| Designation |
Resident |
| Affiliation |
Indira Gandhi Medical College,Shimla |
| Address |
Department of Anesthesia,Indira Gandhi Medical College, Shimla.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8789019496 |
| Fax |
|
| Email |
shristi.shikha94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College,Shimla |
| Address |
Department of Anesthesiology,IGMC, SHIMLA
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418040187 |
| Fax |
|
| Email |
shwetamahajan437@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College,Shimla |
| Address |
Department of Anesthesiology,IGMC, SHIMLA
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418040187 |
| Fax |
|
| Email |
shwetamahajan437@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla, Himachal Pradesh, India PIN CODE-171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Indira Gandhi Medical college, Lakkar Bazaar road, Shimla,Himachal Pradesh, India PIN CODE 171001 |
| 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 Shristi Shikha |
Indira Gandhi Medical College and hospital |
Surgery operation room, Department of Anesthesia, IGMC Shimla
Shimla
HIMACHAL PRADESH |
8789019496
shristi.shikha94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Medical College and hospital, Shimla IGMC, Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. tranexamic acid @ 10mg/kg followed by infusion @ 2mg/kg/hr |
patients will be given inj. tranexamic acid bolus @ 10mg/kg/hr intravenous before incision followed by infusion dose of 2mg/kg/hr intravenous after incision to be continued until closure. |
| Intervention |
Inj. Tranexamic acid bolus 10mg/kg and infusion @ 1ml/kg/hr |
patients will be given inj. tranexamic acid bolus @ 10mg/kg intravenously before incision, followed by infusion @ 1mg/kg/hr intravenous started after incision to be continued until closure of surgery. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III
Age between 25 years-75 years undergoing abdominal oncosurgeries
|
|
| ExclusionCriteria |
| Details |
Refusal to participate in study
Contraindication to the drug
ASA IV,V,VI patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the maximum decrease in perioperative blood loss using two different dosing regimens of tranexamic acid. |
To find the maximum decrease in perioperative blood loss using two different dosing regimens of tranexamic acid by assessing blood loss at the end of surgery, 12, 48 hours after surgery and patients hemoglobin @ 6, 12, 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i)To compare two dosing regimens of tranexamic acid in terms of perioperative blood transfusion requirements and in first 48 hours.
(ii)To compare in terms of post op Hb level at 12, 24 and 48 hours post tranexamic acid bolus and infusion doses respectively |
The comparison of perioperative blood requirement and Hb values at 12, 24 and 48 hours. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="6"
Days="12" |
|
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
|
We planned to study the dosing regimens of Tranexamic acid required to reduce perioperative blood loss in abdominal oncosurgeries as optimum dose and administration schedules of tranexamic acid is still subject of research, aiming at safe inhibition of fibrinolysis in the perioperative period. This study will help in finding the dose of tranexamic acid for maximum reduction in blood loss and will also reduce the transfusion requirements and transfusion related reactions. |