Status:
COMPLETED
Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy?
Lead Sponsor:
University Hospital Hradec Kralove
Conditions:
Robotic-assisted Radical Prostatectomy
Eligibility:
MALE
18-75 years
Phase:
PHASE4
Brief Summary
The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confir...
Detailed Description
Prostate adenocarcinoma is the second most common malignancy and the second most common cause of death due to malignancy in men. Standard treatment includes radical prostatectomy or radiotherapy in pa...
Eligibility Criteria
Inclusion
- Patients scheduled for robotic-assisted radical prostatectomy without pelvic lymph node dissection
- Signed informed consent provided
- Body mass index ≤ 35
- Age of the patient ≤ 75 years
- Operating surgeon with experience \> 100 cases
Exclusion
- Body mass index \> 35
- Age of the patient \> 75 years
- Coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants)
- Thromboembolic, cerebral, or an acute coronary event within the 6 months prior to prostatectomy
- Chronic renal insufficiency (arbitrary cut-off level of creatinine 200 μmol/l)
- Allergic reaction to tranexamic acid
- Operating surgeon with experience \< 100 cases
- Participation in other study
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04319614
Start Date
February 24 2020
End Date
June 30 2022
Last Update
November 9 2022
Active Locations (1)
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1
University Hospital Hradec Králové
Hradec Králové, Czechia, 50005