Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology

Phase 4

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Placebo; Drug: Tranexamic Acid

• Registration Number: NCT02653261
• Lead Sponsor: University Tunis El Manar

Brief Summary

Transurethral resection of the prostate (TURP) represents the gold standard in the operative management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most important complications of urological endoscopic resections is intraoperative and postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury, fluid overload, increased costs and hospital length of stay.

Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery and orthopedic surgical procedures but few studies have assessed the efficacy of this antifibrinolytic agent in urological endoscopic procedures.

The investigators designed this double-blind, placebo controlled study evaluate the safety and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in patients undergoing endoscopic surgery in urology.

Detailed Description

Participants will be randomized into one of two study groups: Group TXA: intravenous tranexamic acid: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The study drug was prepared by an anesthesiologist not involved in the patient management and data collection. The anesthetic technique will be standardized. Serum hemoglobin was measured before and after surgery. The volume of the irrigation fluid, resected prostate weight and duration of resection were recorded.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-03
• Study First Submitted QC: 2016-01-09
• Study First Posted: 2016-01-12
• Primary Completion: 2016-05
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-09
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

1. Adult (>/=18)
2. male or female
3. Undergoing elective TURP or TURBT
4. Spinal anesthesia
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria

1. Atrial fibrillation
2. Coronary artery disease treated with drug eluting stent
3. Severe chronic renal failure
4. Congenital or acquired thrombophilia
5. Known or suspected allergy to tranexamic acid.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	An equal volume of saline
Tranexamic Acid	Tranexamic Acid	Tranexamic Acid (TXA): bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively

Primary Outcome Measures

Name	Time	Method
Number of red blood cell transfusions	From surgery until 72 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
The difference in preoperative and postoperative hematocrit levels to estimate blood loss.	the first postoperative day
Episodes of acute urinary retention	the first postoperative day
Postoperative bleeding with clot retention	the first postoperative day
Episodes of bladder tamponade requiring evacuation or reintervention	the first postoperative day
Postoperative myocardial ischemia assessed by cardiac troponin I	the first postoperative day

Trial Locations

Locations (1)

Ali JENDOUBI; 🇹🇳 Tunis, Tunisia