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

University Tunis El Manar

Status and phase: Completed; Phase 4

Conditions: Hemorrhage

Treatments: Drug: Tranexamic Acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02653261

University Tunis El Manar

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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131 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

An equal volume of saline

Treatment:

Drug: Placebo