Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)

Launched by DR VINCENT MISRAI · Sep 28, 2017

Keywords

ClinConnect Summary

The SOAP trial is studying the safety of a specific prostate surgery called photovaporization (PVP) in men who are taking blood-thinning medications known as anticoagulants. These medications are commonly prescribed to prevent blood clots, especially in older patients. The goal of the trial is to determine whether performing PVP on patients who are on these medications increases the risk of bleeding during or after the surgery.

To be eligible for the study, participants must be men between the ages of 65 and 74 with a prostate size of 30 grams or less, and they must have urinary issues related to benign prostatic hyperplasia (BPH) that haven't improved with medication. Additionally, they need to have been on anticoagulants for at least three months. If you choose to participate, you can expect close monitoring throughout the surgical process, and the trial aims to provide important information that could help improve the safety of prostate surgeries for patients on anticoagulants.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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