Clinical trial · Interventional
PREvention of VENous ThromboEmbolism Following Radical Prostatectomy
A Randomized Controlled Trial for PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (PREVENTER Trial)
NCT03006562CI-TRIAL-00046460PREVENTERterminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early stopping point based on 2nd interim analysis (planned per protocol)
Summary
Brief summary (as posted)
The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deep Venous Thrombosis | — | UNRESOLVED | — |
| Lymphocele After Surgical Procedure | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Pulmonary Embolism | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subcutaneous Heparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Subcutaneous Heparin
- description
- Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge.
- interventionNames
- Drug: Subcutaneous Heparin
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.
Primary outcomes (3)
- measure
- Number of Participants With Symptomatic Venous Thromboembolism
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Men 18-100 years of age with histologically confirmed prostate cancer of any stage undergoing RP * Patients who would have otherwise been eligible to receive routine post-RP care Exclusion Criteria: * Active treatment for VTE * Patients judged by patients' urologist, primary care doctor, or in the preoperative evaluation center (PEC) to be unsafe to forgo pharmacologic prophylaxis or systemic anticoagulation postoperatively (whether or not patients are on systematic anticoagulation for indications other than VTE) * Known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy) * Epidural analgesia * Spinal anesthesia * Participation in a different trial that increases a patient's risk of VTE
References
Publications (4)
- BACKGROUNDHuang MM, Su ZT, Becker REN, Pavlovich CP, Partin AW, Allaf ME, Patel HD. Complications after open and robot-assisted radical prostatectomy and association with postoperative opioid use: an analysis of data from the PREVENTER trial. BJU Int. 2021 Feb;127(2):190-197. doi: 10.1111/bju.15172. Epub 2020 Aug 17. PMID 32654363
- RESULTPatel HD, Faisal FA, Trock BJ, Joice GA, Schwen ZR, Pierorazio PM, Johnson MH, Bivalacqua TJ, Han M, Gorin MA, Carter HB, Partin AW, Pavlovich CP, Allaf ME. Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial. Eur Urol. 2020 Sep;78(3):360-368. doi: 10.1016/j.eururo.2020.05.001. Epub 2020 May 19. PMID 32444264
- DERIVEDPatel HD, Faisal FA, Patel ND, Pavlovich CP, Allaf ME, Han M, Herati AS. Effect of a prospective opioid reduction intervention on opioid prescribing and use after radical prostatectomy: results of the Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES) Initiative. BJU Int. 2020 Mar;125(3):426-432. doi: 10.1111/bju.14932. Epub 2019 Nov 15. PMID 31643128
- DERIVEDPatel HD, Srivastava A, Patel ND, Faisal FA, Ludwig W, Joice GA, Schwen ZR, Allaf ME, Han M, Herati AS. A Prospective Cohort Study of Postdischarge Opioid Practices After Radical Prostatectomy: The ORIOLES Initiative. Eur Urol. 2019 Feb;75(2):215-218. doi: 10.1016/j.eururo.2018.10.013. Epub 2018 Oct 21. PMID 30352714