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

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653261
• Other study ID #: University Tunis El Manar
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2016
• Last updated: October 9, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
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
• Placebo
An equal volume of saline

Locations

Country	Name	City	State
Tunisia	Ali JENDOUBI	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of red blood cell transfusions		From surgery until 72 hours postoperatively	Yes
Secondary	The difference in preoperative and postoperative hematocrit levels to estimate blood loss.		the first postoperative day	Yes
Secondary	Episodes of acute urinary retention		the first postoperative day	Yes
Secondary	Postoperative bleeding with clot retention		the first postoperative day	Yes
Secondary	Episodes of bladder tamponade requiring evacuation or reintervention		the first postoperative day	Yes
Secondary	Postoperative myocardial ischemia assessed by cardiac troponin I		the first postoperative day	Yes