Hemorrhage
Conditions
Keywords
tranexamic acid, Transurethral Resection of the Prostate (TURP), Transurethral Resection of a Bladder Tumor (TURBT), Hemorrhage, Blood Transfusion
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.
Interventions
DRUGTranexamic 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
DRUGPlacebo
An equal volume of saline
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of red blood cell transfusions | From surgery until 72 hours postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| The difference in preoperative and postoperative hematocrit levels to estimate blood loss. | the first postoperative day |
| Episodes of acute urinary retention | the first postoperative day |
| Postoperative bleeding with clot retention | the first postoperative day |
| Episodes of bladder tamponade requiring evacuation or reintervention | the first postoperative day |
| Postoperative myocardial ischemia assessed by cardiac troponin I | the first postoperative day |
Countries
Tunisia
Outcome results
None listed