| CTRI Number |
CTRI/2024/10/075515 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of tranexamic acid via intravenous and irrigation fluid route in controlling TURP-associated bleeding |
|
Scientific Title of Study
|
Efficacy of Intravenous and Topical Tranexamic Acid to Control Perioperative Blood Loss in Bipolar TURP |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoj Kiran Vaidya |
| Designation |
Senior Resident cum PG |
| Affiliation |
BLDE Deemed to be University |
| Address |
Department of Urology, BLDE Deemed to be University, Vijayapura
Bijapur
KARNATAKA
591306
India |
| Phone |
9742350061 |
| Fax |
|
| Email |
manoj.vaidya@bldedu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay s Kundargi |
| Designation |
PROFESSOR |
| Affiliation |
BLDE Deemed to be University |
| Address |
Dept of Urology, BLDE DEEMED TO BE UNIVERSITY
Bijapur
KARNATAKA
591306
India |
| Phone |
9448897564 |
| Fax |
|
| Email |
vinayuro@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Kiran Vaidya |
| Designation |
Senior Resident cum PG |
| Affiliation |
BLDE Deemed to be University |
| Address |
Department of Urology, BLDE Deemed to be University, Vijayapura
Bijapur
KARNATAKA
591306
India |
| Phone |
9742350061 |
| Fax |
|
| Email |
manoj.vaidya@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| BLDE Deemed to be University |
|
|
Primary Sponsor
|
| Name |
BLDE (Deemed to be University), Shri B M Patil Medical College Hospital & Research Centre |
| Address |
Smt Bangaramma Sajjan Campus,
Solapur Road, Vijayapura, Karnataka- 586103 |
| Type of Sponsor |
Private 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 |
| Manoj Vaidya |
BLDE Deemed to be University, Shri B M Patil Medical College Hospital and Research Centre |
Department of Urology, 2nd Floor, Superspeciality block, Smt Bangaramma Sajjan Campus, Solapur Road, Vijayapura
Bijapur
KARNATAKA |
9742350061
manoj.vaidya@bldedu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BLDE (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I/V Tranexamic Acid Group |
1gm I/V Tranexamic acid to be administered 20 min before surgery. |
| Intervention |
Irrigation Fluid Tranexamic Acid Group |
500 mg of Tranexamic acid will be added to each 3 Litre normal saline irrigation bottle up to a maximum of 2 gm. (12 L Irrigation fluid). No Tranexamic acid to be added to the irrigation fluid beyond 12L. |
| Comparator Agent |
Placebo group |
this group will not receive Tranexamic acid via either I/V or Irrigation fluid route |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
1. Bothersome LUTS and proven prostatic enlargement based on digital rectal examination and abdominal ultrasonography with gland size 40-100 cc
2. Age 50-90 years |
|
| ExclusionCriteria |
| Details |
1. History or evidence of prostate disease other than BPH, previous prostate surgery
2. Severe cardiopulmonary disease
3. Patients requiring treatment with anti-platelets, or anticoagulants in the immediate perioperative period and severe medical conditions such as liver disease, or bleeding disorders
4. End Stage Renal Disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Drop in the Haemoglobin and Hematocrit level
2. Any Change in the Volume of irrigation fluid used after TURP
3. complications- specifically Deep Vein Thrombosis. |
4 Hrs, 24hrs and 1 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Clot retention or hematuria or deep vein thrombosis |
1 month 3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
29/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Background and study aims The role of tranexamic acid (TXA) in urologic surgery, and especially transurethral resection of the prostate (TURP), is under investigation, and a few studies in support of its efficacy have been published. However, there needs to be more consensus regarding dose, route of administration and efficacy profile for TXA during TURP. This study aims to evaluate the efficacy, safety and preferred route of administering TXA to control TURP-associated bleeding- either by intravenous route or the irrigation fluid route to directly target the bleeding site, while comparing it with the control group.
Study hypothesis- Administration of tranexamic acid (TXA) via intravenous and irrigation fluid routes significantly reduces the incidence and severity of bleeding during transurethral resection of the prostate (TURP) compared to standard care, with the intravenous route demonstrating superior efficacy in controlling intraoperative blood loss and improving postoperative outcomes.
Study Design- This is a prospective single-centre intervention study with patients undergoing transurethral resection of the prostate (TURP) for lower urinary tract symptoms (LUTS ) attributable to benign prostatic hyperplasia (BPH) and gland size between 40-100 g and aged between 50-90 years being allocated into 3 groups: Group 1- Receiving 1 gm tranexamic acid intravenously 20 min before TURP Group 2- Receiving 500 mg tranexamic acid in every 3 litres of irrigation fluid (Up to a maximum of 2 gm) Group 3- Control/Placebo group The study participants will be randomised into 3 groups using the block randomisation technique. It will be a single-blinded study. Blood loss will be estimated by recording haemoglobin and hematocrit 4 h post-operatively and on the first postoperative day. Other parameters such as resection time, intraoperative endoscopic vision, irrigation fluid volume and complications will be noted.
Possible benefits and risks to participating patients Benefit- Reduction in TURP associated blood loss. Reduced requirement for blood transfusion. Risk- Marginally increased risk of Deep Vein Thrombosis (DVT)
|