Skip to content

To study the safety and effect of tranexamic acid drug in transurethral resection of prostate surgery for benign prostatic hyperplasia patients.

A prospective randomized double blind study on the efficacy and safety of intra-operative tranexamic acid in transurethral resection of prostate - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056336
Enrollment
80
Registered
2023-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N996- Intraoperative hemorrhage and hematoma of a genitourinary system organ or structure complicating a procedure Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: TARNEXAMIC ACID DRUG: Intravenous administration of tranexamic acid drug 10mg/kg single stat dose at the time of induction of anesthesia, in transurethral resection of prostate Control

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who required surgical intervention for BPH 2. Prostate weight (30 -100 cc) 3. Preoperative Hb more than 10 mg/dl 4. Age 50 to 80 years 5. ASA ⩽III 6. Age specific PSA range

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Coagulopathies 3. Dual anti-platelets or clopidogrel drugs users 4. Ischaemic heart diseases and arrhythmia 5. History of PTE and DVT 6. History of CVA 7. Renal failure (serum creatinine >1.3 mg / dl) 8. Carcinoma of prostate 9. History of tranexamic acid sensitivity

Design outcomes

Primary

MeasureTime frame
1.To reduce the perioperative blood loss in transurethral resection of prostate 2. To reduce the requirement of urinary bladder irrigation fluid volume. 3. To reduce the mean operative time, & hospital stay 4. To reduce the requirement of blood transfusion. Timepoint: 48 HOURS

Secondary

MeasureTime frame
To reduce the chances of bladder wash & re-exploration.Timepoint: 7 DAYS

Countries

India

Contacts

Public ContactGANESAN G

SRI NARAYANI HOSPITAL AND RESEARCH CENTRE

urosiva@gmail.com7598046755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026