Clinical trial NCT02653261: Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology
Official title: Safety and Efficacy of Intravenous Tranexamic Acid in Reducing Blood Transfusion After Endoscopic Transurethral Resections in Urology: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Keywords: tranexamic acid
Transurethral Resection of the Prostate (TURP)
Transurethral Resection of a Bladder Tumor (TURBT)
Hemorrhage
Blood Transfusion
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of red blood cell transfusions
timeFrame: From surgery until 72 hours postoperatively
Secondary outcomes:
measure: The difference in preoperative and postoperative hematocrit levels to estimate blood loss.
timeFrame: the first postoperative day
measure: Episodes of acute urinary retention
timeFrame: the first postoperative day
measure: Postoperative bleeding with clot retention
timeFrame: the first postoperative day
measure: Episodes of bladder tamponade requiring evacuation or reintervention
timeFrame: the first postoperative day
measure: Postoperative myocardial ischemia assessed by cardiac troponin I
timeFrame: the first postoperative day
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Ali JENDOUBI
Study officials:
affiliation: University Tunis El Manar
name: Ali JENDOUBI
role: PRINCIPAL_INVESTIGATOR
References: