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Trial record 47 of 419 for:    TRANEXAMIC ACID

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

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ClinicalTrials.gov Identifier: NCT02653261
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Ali JENDOUBI, University Tunis El Manar

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.


Condition or disease Intervention/treatment Phase
Hemorrhage Drug: Tranexamic Acid Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid
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
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 Name: Exacyl

Placebo Comparator: Placebo
An equal volume of saline
Drug: Placebo
An equal volume of saline
Other Name: Saline




Primary Outcome Measures :
  1. Number of red blood cell transfusions [ Time Frame: From surgery until 72 hours postoperatively ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653261


Locations
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Tunisia
Ali JENDOUBI
Tunis, Tunisia, 1006
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Principal Investigator: Ali JENDOUBI University Tunis El Manar

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Responsible Party: Ali JENDOUBI, MD, Assistant Professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT02653261     History of Changes
Other Study ID Numbers: University Tunis El Manar
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ali JENDOUBI, University Tunis El Manar:
tranexamic acid
Transurethral Resection of the Prostate (TURP)
Transurethral Resection of a Bladder Tumor (TURBT)
Hemorrhage
Blood Transfusion
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants