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

Primary Purpose

Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhage focused on measuring tranexamic acid, Transurethral Resection of the Prostate (TURP), Transurethral Resection of a Bladder Tumor (TURBT), Hemorrhage, Blood Transfusion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ali JENDOUBI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm Description

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

An equal volume of saline

Outcomes

Primary Outcome Measures

Number of red blood cell transfusions

Secondary Outcome Measures

The difference in preoperative and postoperative hematocrit levels to estimate blood loss.
Episodes of acute urinary retention
Postoperative bleeding with clot retention
Episodes of bladder tamponade requiring evacuation or reintervention
Postoperative myocardial ischemia assessed by cardiac troponin I

Full Information

First Posted
January 3, 2016
Last Updated
October 9, 2016
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT02653261
Brief Title
Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
tranexamic acid, Transurethral Resection of the Prostate (TURP), Transurethral Resection of a Bladder Tumor (TURBT), Hemorrhage, Blood Transfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An equal volume of saline
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Exacyl
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
An equal volume of saline
Primary Outcome Measure Information:
Title
Number of red blood cell transfusions
Time Frame
From surgery until 72 hours postoperatively
Secondary Outcome Measure Information:
Title
The difference in preoperative and postoperative hematocrit levels to estimate blood loss.
Time Frame
the first postoperative day
Title
Episodes of acute urinary retention
Time Frame
the first postoperative day
Title
Postoperative bleeding with clot retention
Time Frame
the first postoperative day
Title
Episodes of bladder tamponade requiring evacuation or reintervention
Time Frame
the first postoperative day
Title
Postoperative myocardial ischemia assessed by cardiac troponin I
Time Frame
the first postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (>/=18) male or female Undergoing elective TURP or TURBT Spinal anesthesia Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2. Exclusion Criteria: Atrial fibrillation Coronary artery disease treated with drug eluting stent Severe chronic renal failure Congenital or acquired thrombophilia Known or suspected allergy to tranexamic acid.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali JENDOUBI
Organizational Affiliation
University Tunis El Manar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ali JENDOUBI
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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