Overview

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

Status:
Completed

Trial end date:
2016-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Tunis El Manar

Treatments:

Tranexamic Acid

Criteria

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.