Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-04 @ 4:28 PM
Study NCT ID:
NCT02653261
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology
Sponsor:
University Tunis El Manar
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: