|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2016 |
|
Main ID: |
NCT02653261 |
|
Date of registration:
|
03/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology
|
|
Scientific 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 |
|
Date of first enrolment:
|
January 2016 |
|
Target sample size:
|
131 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02653261 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Tunisia
| | | | | | | |
|
Contacts
|
|
Name:
|
Ali JENDOUBI |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Tunis El Manar |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hemorrhage
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Tranexamic Acid
|
|
Primary Outcome(s)
|
|
Number of red blood cell transfusions
[Time Frame: From surgery until 72 hours postoperatively]
|
|
Secondary Outcome(s)
|
|
Episodes of bladder tamponade requiring evacuation or reintervention
[Time Frame: the first postoperative day]
|
|
Episodes of acute urinary retention
[Time Frame: the first postoperative day]
|
|
Postoperative myocardial ischemia assessed by cardiac troponin I
[Time Frame: the first postoperative day]
|
|
The difference in preoperative and postoperative hematocrit levels to estimate blood loss.
[Time Frame: the first postoperative day]
|
|
Postoperative bleeding with clot retention
[Time Frame: the first postoperative day]
|
|
Secondary ID(s)
|
|
University Tunis El Manar
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|