PREvention of VENous ThromboEmbolism Following Radical Prostatectomy

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.

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 their 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 they 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