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NCT Number: NCT02653261

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

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.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ali JENDOUBI

Tunis, Tunis Governorate, 1006, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tranexamic Acid

Drug

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: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively

Other names: Exacyl

Placebo

Drug

An equal volume of saline

Other names: Saline

Primary outcomes

  1. Number of red blood cell transfusions

    Time frame: From surgery until 72 hours postoperatively

Secondary outcomes

  1. The difference in preoperative and postoperative hematocrit levels to estimate blood loss.

    Time frame: the first postoperative day

  2. Episodes of acute urinary retention

    Time frame: the first postoperative day

  3. Postoperative bleeding with clot retention

    Time frame: the first postoperative day

  4. Episodes of bladder tamponade requiring evacuation or reintervention

    Time frame: the first postoperative day

  5. Postoperative myocardial ischemia assessed by cardiac troponin I

    Time frame: the first postoperative day

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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