| CTRI Number |
CTRI/2023/11/060390 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of tranexamic acid in reducing blood loss during caesarean section |
|
Scientific Title of Study
|
Efficacy of tranexamic acid in reducing perioperative blood loss during caesarean section- a 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 |
Albin Joseph |
| Designation |
PG RESIDENT |
| Affiliation |
MOSC Medical College, Kolenchery |
| Address |
Department of Anaesthesiology and critical care
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9497769011 |
| Fax |
|
| Email |
albinjoseph876@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sam Philip |
| Designation |
Professor |
| Affiliation |
MOSC Medical college, Kolenchery |
| Address |
Department of Anaesthesiology and critical care
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447209010 |
| Fax |
|
| Email |
drsam_p@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Albin Joseph |
| Designation |
PG RESIDENT |
| Affiliation |
MOSC Medical college, Kolenchery |
| Address |
Department of Anaesthesiology and critical care
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9497769011 |
| Fax |
|
| Email |
albinjoseph876@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical College
Kolenchery, Ernakulam
Kerala
India
682311 |
|
|
Primary Sponsor
|
| Name |
Albin Joseph |
| Address |
MOSC MEDICAL COLLEGE KOLENCHERY |
| 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 |
| Albin Joseph |
Department of Anaesthesiology and critical care |
MOSC MEDICAL COLLEGE
Kolenchery
Ernakulam
KERALA |
9497769011
albinjoseph876@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MOSC Medical College Kolenchery |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
100ml normal saline |
100ml normal saline is given 10mins before incision of caesarean section. Patients hb preoperatively and after 48hrs will be obtained. Effectiveness of tranexamic acid will be assessed by estimating mean haemoglobin mass loss, which inturn is obtained by hb of patient preoperatively and after 48hrs and by the blood volume(calculated using Nadlers formula) |
| Intervention |
1gram of tranexamic acid in 100ml normal saline |
1gram of tranexamic acid in 100ml normal saline is given 10mins before incision of caesarean section. Patients hb preoperatively and after 48hrs will be obtained. Effectiveness of tranexamic acid will be assessed by estimating mean haemoglobin mass loss, which inturn is obtained by hb of patient preoperatively and after 48hrs and by the blood volume(calculated using Nadlers formula) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA 2 parturients for elective caesarean section.
Singleton pregnancy. |
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable pregnant women.
Patients with history of DVT and other thromboembolic events in the past. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the perioperative blood loss in caesarean section |
48hr after caesarean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction of tranexamic acid |
Perioperative, 48hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 4 |
|
Date of First Enrollment (India)
|
12/12/2023 |
| 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="1" |
|
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
|
This study is performed to evaluate the efficacy of tranexamic acid in reducing perioperative blood loss during caesarean section. A randomized controlled study will be conducted over a period of 1year 6 months on 76 pregnant women of ASA II, undergoing caesarean section under subarachanoid block. All patients are subjected to a thorough preanesthetic evaluation, the study is explained in detail and written informed consent is obtained. Patients are randomly divided into two groups of 38 each. 10 minutes before the incision, group A receives 100ml of normal saline and group B receives 1gm of tranexamic acid in 100ml of normal saline.Effectiveness of tranexamic acid in reducing perioperative blood loss will be assessed by estimating mean haemoglobin(Hb) mass loss which is obtained from patient’s Hb preoperatively and 48 hrs after caesarean section and the blood volume, which is calculated using Nader’s formula. Data analysis will be done using appropriate statistical tests. |