| CTRI Number |
CTRI/2024/04/065861 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
To study the effectiveness of tranexamic acid in reducing blood loss and postoperative complications in patients undergoing breast surgery |
|
Scientific Title of Study
|
Study of efficacy of tranexamic acid in reducing blood loss and postoperative complications in breast 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 Hariharan R |
| Designation |
Resident |
| Affiliation |
Govt Stanley medical college |
| Address |
7th floor I Block
Department of General Surgery Govt Stanley medical college
1 old jail road
George Town
Chennai
TAMIL NADU
600001
India |
| Phone |
9952559759 |
| Fax |
|
| Email |
hariharan.0101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B sathyapriya |
| Designation |
Professor |
| Affiliation |
Govt Stanley medical college |
| Address |
7 th floor I block
Department of General Surgery
Govt stanley medical college
1 old jail road
George town
Chennai
TAMIL NADU
600001
India |
| Phone |
94444086644 |
| Fax |
|
| Email |
drbspriya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Hariharan R |
| Designation |
Resident |
| Affiliation |
Govt Stanley medical college |
| Address |
Department of General Surgery Govt Stanley medical college 1 old jail road George Town
TAMIL NADU
600001
India |
| Phone |
9952559759 |
| Fax |
|
| Email |
hariharan.0101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Stanley medical college
1 old jail road
George Town
Chennai 600001 |
|
|
Primary Sponsor
|
| Name |
Dr Hariharan R |
| Address |
7th floor I block
Department of general surgery Govt Stanley medical college
1 old jail road
George Town
Chennai 600 001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Hariharan R |
Govt Stanley medical college |
Wing a, 8th floor,I BLOCK,department of General Surgery,Govt stanley medical college, 1,old jail road George Town
Chennai
TAMIL NADU |
9952559759
hariharan.0101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley medical college and hospital chennai 01 Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Tranaxemic acid |
1 g Intravenous tranexamic acid preoperative and 3 doses in the 1st 24 hrs postoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
All females above 18 yrs of age undergoing breast surgery who consent to the study |
|
| ExclusionCriteria |
| Details |
Patients not giving consent
Patients with uncontrolled comorbidities
History of prior thromboembolic events
Patients with severe renal impairment
Patients with seizure disorder
Patients with retinal vein occlusion |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Effect of tranexamic acid in reducing postoperative bleeding
2 effect of tranexamic acid in reducing postoperative pain
3 effect of tranexamic acid in reducing other postoperative complications |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 Effect of tranexamic acid in reducing other postoperative complications |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Aim to study the effect of tranexamic acid in reducing blood loss and postoperative complications in patients undergoing breast surgery 1g tranexamic acid will be given to the study group 1 dose preoperative and 3 doses in the 1st 24 hrs postoperative period and the postoperative pain and blood loss will be compared to the control group |