A Phase 4 interventional study of Tranexamic Acid and Placebo in Hemorrhage, sponsored by University Tunis El Manar. Completed at 1 site in Tunisia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-10-11.
Sponsored by University Tunis El Manar · Phase 4, Interventional, and Prevention
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 131 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →University Tunis El Manar is the lead sponsor of 73 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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
Drug: Tranexamic Acid
An equal volume of saline
Drug: Placebo
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
Also known as: Exacyl
An equal volume of saline
Also known as: Saline
Number of red blood cell transfusions
Time frame: From surgery until 72 hours postoperatively
The difference in preoperative and postoperative hematocrit levels to estimate blood loss.
Time frame: the first postoperative day
Episodes of acute urinary retention
Time frame: the first postoperative day
Postoperative bleeding with clot retention
Time frame: the first postoperative day
Episodes of bladder tamponade requiring evacuation or reintervention
Time frame: the first postoperative day
Postoperative myocardial ischemia assessed by cardiac troponin I
Time frame: the first postoperative day
Plan to share: No
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University Tunis El Manar