PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (PREVENTER)

Johns Hopkins University

Status and phase

Terminated

Phase 4

Conditions

Pulmonary Embolism

Venous Thromboembolism

Deep Venous Thrombosis

Lymphocele After Surgical Procedure

Prostate Cancer

Treatments

Drug: Subcutaneous Heparin

Study type

Interventional

Funder types

Other

Identifiers

NCT03006562

IRB00123618

Details and patient eligibility

About

Full 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.

Enrollment

501 patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

501 participants in 2 patient groups

Subcutaneous Heparin

Experimental group

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.

Treatment:

Drug: Subcutaneous Heparin

Control

No Intervention group

Description:

Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.

Trial documents