NCT03006562

PREvention of VENous ThromboEmbolism Following Radical Prostatectomy

A Randomized Controlled Trial for PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (PREVENTER Trial)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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). Currently, there is no standard practice for VTE prophylaxis after RP with the American Urological Association recommending "pharmacological or pneumatic mechanical prophylaxis" for high risk patients. Prior studies showed 30% of patients in the United States received no perioperative prophylaxis and less than 20% received pharmacologic agents, compared to 98% of patients receiving pharmacologic prophylaxis in the United Kingdom. Some urologists prescribe patients low molecular weight heparin (LMWH) after discharge for up to 30 days after surgery. Additionally, there are no established risks of pharmacologic prophylaxis for RP patients, but some urologists express concern about the potential impact of prophylaxis on the rate of postoperative lymphoceles or hematomas. At Johns Hopkins, patients do not routinely receive pharmacologic VTE prophylaxis in the perioperative setting for RP. Given the lack of standard practice and implications for patient safety, the investigators propose a prospective, stratified randomized controlled trial to evaluate the impact of perioperative pharmacologic prophylaxis on VTE following RP hypothesizing that it will prevent VTE events without significantly impacting the rate of postoperative bleeding or lymphoceles. The potential impact of surveillance bias with differential imaging between arms, effect of lymphadenectomy (yes/no and number of noted removed) or surgical approach (robotic and open), and differences by patients risk (comorbidity and VTE risk based on components of the Caprini score) or demographics will be assessed.

Conditions

• Prostate Cancer
• Venous Thromboembolism
• Lymphocele After Surgical Procedure
• Deep Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Subcutaneous Heparin	5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-12-30
• Last updated: 2020-08-05
• Results posted: 2020-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study