| CTRI Number |
CTRI/2023/03/050390 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the efficacy of preoperative IV Tranexenamic acid in reducing intraoperative blood loss in cancer patients |
|
Scientific Title of Study
|
The Effect of Preoperative IV Tranexamic acid on intraoperative blood loss in cancer surgeries at a tertiary care centre in South India – A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Tirunelveli Medical college |
| Address |
Department of Surgical oncology,
Tirunelveli medical college Hospital,
Tirunelveli
plot no 130, 5th street Teachers colony
Tirunelveli
TAMIL NADU
627011
India |
| Phone |
9500018478 |
| Fax |
|
| Email |
oncodeepa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEEPA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Tirunelveli Medical college |
| Address |
Department of Surgical Oncology,
Tirunelveli medical college Hospital,
Tirunelveli
Tirunelveli
TAMIL NADU
627011
India |
| Phone |
9500018478 |
| Fax |
|
| Email |
oncodeepa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DEEPA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Tirunelveli Medical college |
| Address |
Department of Surgical Oncology,
Tirunelveli medical college hospital,
Tirunelveli
Tirunelveli
TAMIL NADU
627011
India |
| Phone |
9500018478 |
| Fax |
|
| Email |
oncodeepa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tirunelveli medical college Hospital, Tirunelveli |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [no sponsor] |
|
|
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 |
| DEEPA |
Tirunelveli medical college Hospital |
Department of Surgical Oncology,
Tirunelveli
TAMIL NADU |
9500018478
oncodeepa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tirunelveli Medical College Institutional research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (3) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (4) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (5) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (6) ICD-10 Condition: O||Medical and Surgical, (7) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo |
100 ml of normal saline infusion given once 15 minutes before the onset of surgery |
| Intervention |
tranexamic acid |
1 gm (2 vials; each vial 500mg) of Tranexemic acid is injected into 100 ml of normal saline and it is given via intravenous infusion once 15 minutes before the onset of surgery. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all cancer patients undergoing surgeries for breast gyanecology, Head &neck ,GI, soft tissue sarcoma& others |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy(activated partial thromboplastin time >50 s or International normalised ratio >1.5, platelets <50 X 109/L), Recent history of acetylsalicylic acid ingestion (< 5 days), Patients on anticoagulation therapy (received heparin within 4 hours or received warfarin 3 days preoperatively), Those with known peripheral vascular disease, Pre-existing renal dysfunction (serum creatinine >1.2 mg/dl), Liver dysfunction, Known allergy to tranexamic acid
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Operative blood loss
2. Blood transfusion rates
|
baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Length of hospital stay
2. Length of stay in ICU
3. DVT
4. Pulmonary embolism
|
5 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
08/03/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To determine the impact of preoperative administration of tranexamic acid on 1. Intra-operative blood loss and 2. transfusion rates in major oncological surgeries |