| CTRI Number |
CTRI/2025/03/081587 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of intravenous tranexamic acid in reducing p blood loss in abdominal hysterectomy surgery |
|
Scientific Title of Study
|
Efficacy of intravenous tranexamic acid in reducing perioperative blood loss in abdominal hysterectomy- A double blinded randomized controlled 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 |
satabdi bhattacharjee |
| Designation |
post graduate trainee |
| Affiliation |
Tezpur medical college and hospital |
| Address |
department of obstetrics and gynaecology, tezpur medical college and hospital
Sonitpur
ASSAM
784153
India |
| Phone |
9401168263 |
| Fax |
|
| Email |
satabdibhattacharjee98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Radha Rashmi Baruah |
| Designation |
Assistant Professor |
| Affiliation |
Tezpur medical college and hospital |
| Address |
department of obstetrics and gynaecology, tezpur medical College and hospital
Sonitpur
ASSAM
784153
India |
| Phone |
9864013158 |
| Fax |
|
| Email |
radharashmi2014@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
satabdi bhattacharjee |
| Designation |
post graduate trainee |
| Affiliation |
Tezpur medical college and hospital |
| Address |
department of obstetrics and gynaecology, tezpur medical College and hospital
Sonitpur
ASSAM
784153
India |
| Phone |
9401168263 |
| Fax |
|
| Email |
satabdibhattacharjee98@gmail.com |
|
|
Source of Monetary or Material Support
|
| tezpur medical college and hospital. tezpur , 784153 |
|
|
Primary Sponsor
|
| Name |
Tezpur medical college and hospital |
| Address |
tezpur medical college and hospital,bihaguri 784010, Assam, India |
| 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 |
| satabdi bhattacharjee |
Tezpur Medical college and hospital |
department of obstetrics and gynaecology, gynae OT,Tezpur medical college and hospital
Sonitpur
ASSAM |
09401168263
satabdibhattacharjee98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal saline |
10 ml to be given 5 miniutes before skin incision,will act as placebo |
| Intervention |
tranexamic acid injection |
1gram of tranexamic acid 5 minutes before skin incision. it is an antifibrinolytic agent used to reduce blood loss
Total duration: 5 minutes before skin incision |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Women undergoing total abdominasl hysterectomy with or without bilateral salpingo-oophorectomy due to myoma, menorrhagia, abnormal uterine bleeding, fibroid, adenomyosis |
|
| ExclusionCriteria |
| Details |
patients with cardiac, renal, thromboembolic disease, adnexal mass and malignancy, pre existing anemia, allergy to tranexamic acid, anti coagulant therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| estimated blood loss by weight, estimated blood loss by suction drain |
during ot, just postop, upto 24 hours postop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| use of topical hemostatics, blood transfusion, drop in hb level |
during ot, post-operative upto 24 hours postop |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
13/03/2025 |
| 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="1"
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
|
It is a randomized controlled trial where patients undergoing total abdominal hysterectomy for benign conditions will be taken as study group, one group (test) will be randomly allocated to be given tranexamic acid preoperatively and the other (control) group will be given placebo. perioperative blood loss in both the groups will be compared to establish the efficacy of tranexamic acid in reducing perioperative blood loss |