| CTRI Number |
CTRI/2024/03/064938 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Tranexamic acid (drug preventing breakdown of blood clots) on the blood loss occurring during debridement (removal of dead and devitalized tissue) in patients with soft tissue infection |
|
Scientific Title of Study
|
Effect of tranexamic acid on intraoperative blood loss in patients undergoing debridement for necrotizing soft tissue infections: 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 |
Nivetha Baskaran |
| Designation |
Junior Resident |
| Affiliation |
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthri Nagar, Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9677789961 |
| Fax |
|
| Email |
Nivethabaskaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasis Naik |
| Designation |
Associate Professor |
| Affiliation |
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthri Nagar, Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8763124660 |
| Fax |
|
| Email |
debasismbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivetha Baskaran |
| Designation |
Junior Resident |
| Affiliation |
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthri Nagar, Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9677789961 |
| Fax |
|
| Email |
Nivethabaskaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthri Nagar, Gorimedu, Puducherry - 605006, India |
|
|
Primary Sponsor
|
| Name |
Nivetha Baskaran |
| Address |
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthri Nagar, Gorimedu, Puducherry - 605006. |
| 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 Nivetha Baskaran |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Surgery, Hospital Block, Dhanvanthri Nagar, Gorimedu, Puducherry - 605006.
Pondicherry
PONDICHERRY |
9677789961
Nivethabaskaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Dose: 10 ml of Normal saline intravenously over 20 mins.
Frequency: Single dose
Duration: Before beginning the surgery. |
| Intervention |
Tranexamic acid 1g |
Dose: 1 g Tranexamic acid will be given intravenously over 20 minutes.
Frequency: Single dose
Duration: Before beginning the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years undergoing debridement for necrotizing soft tissue infection. |
|
| ExclusionCriteria |
| Details |
Patients on anti-platelets.
Patients on anti-coagulants.
Pregnancy
Patients with a history of MI, TIA, CVA, DVT, and PTE.
Patients denying consent.
Patients hypersensitive to tranexamic acid or its constituent preservative. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intraoperative blood loss/ square centimeter of the debrided area in patients undergoing debridement for necrotizing soft tissue infection, with and without tranexamic acid. |
Intraoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the intraoperative fluid administration.
To compare the transfusion values (intraoperative and postoperative).
To compare the incidence of vascular occlusive events (myocardial infarction, stroke, deep vein thrombosis, and pulmonary thromboembolism).
|
Intraoperative till the time of discharge. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
New strategies focused on reducing blood loss are emerging and
encouraging. Of these, bipolar diathermy, harmonic scalpel, local
vasoconstrictors, induced hypotension, tourniquet application, and
antifibrinolytic agents are the most widely used techniques. Tranexamic acid is a synthetic antifibrinolytic agent 7 -10 times more potent
than Epsilon-aminocaproic acid. It competitively blocks the lysine-binding site
of plasminogen, plasmin, and tissue plasminogen activator, preventing their
association with fibrin. Plasminogen conversion to plasmin is thus retarded,
and the proteolytic action of plasmin on fibrin monomers and fibrinogen is
debarred We expect tranexamic
acid to reduce intraoperative blood loss, the requirement for blood
transfusion, and the hospital stay in patients undergoing debridement for
necrotizing soft tissue infections.
After registering the trial in CTRI, patients satisfying the inclusion and exclusion criteria will be recruited into the trial. In the intervention group, patients with necrotizing soft tissue infection will receive 1 g of tranexamic acid and patients in the control group will receive 10 ml of normal saline intravenously over 20 mins before beginning the surgery. Debridement will be performed as per the standard of care and intraoperative parameters like blood loss, requirement of blood transfusions, intravenous fluids will be compared between the two groups. Postoperative care will be the same for both the groups and complications like Deep vein thrombosis, Myocardial infarction, Transient ischemic attack. Pulmonary thromboembolism will be compared. |