Status:
RECRUITING
Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)
Lead Sponsor:
Dr Vincent Misrai
Collaborating Sponsors:
Boston Scientific Corporation
Iqvia Pty Ltd
Conditions:
Benign Prostatic Hyperplasia
Anticoagulant Adverse Reaction
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (...
Detailed Description
SOAP is a non-inferiority, multicentric, open-labelled, two parallel arms study. The expected benefits are to foster and make the perioperative management of OAC safer in patients undergoing BPH surg...
Eligibility Criteria
Inclusion
- Prostate volume \< or = 30 gr
- Micturition disorders resistant to medical treatment related to HBP and/or complications related to BPH (retention, lithiasis...)
- Patient candidate for photovaporization of the prostate
- Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months
- Unprotected major
- Patient affiliated to a social security scheme or equivalent
- Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form.
Exclusion
- History of prostate cancer
- Previous pelvic radiotherapy
- History of stenosis of the urethra
- Patient with one or more bladder polyps
- Patient under antiplatelet agent other than aspirin
- Allergy to heparin or history of heparin-induced thrombocytopenia
- Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux)
- Any mechanical prosthetic heart valve
- Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks
- Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks
- Major bleeding within past 6 weeks
- Severe renal insufficiency (calculated creatinine clearance \< 30 mL / min)
- Thrombocytopenia (platelet count \< 100 x 10\^9 / L)
- Life expectancy \< 1 month
- Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility)
- Contra-indication to PVP surgery or contra-indication to general anesthesia
- Protected patients : majors under some form of guardianship
- Patient participating in another clinical study
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT03297281
Start Date
October 30 2017
End Date
May 31 2026
Last Update
June 20 2025
Active Locations (1)
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1
Clinique Pasteur
Toulouse, France, 31 076