Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Thrombosis

Pulmonary Embolism

Embolism

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Lymphocele

Embolism and Thrombosis

Vascular Diseases

Lung Diseases

Respiratory Tract Diseases

Cysts

Lymphatic Diseases

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Heparin

Calcium heparin

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.

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

5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.

Subcutaneous Heparin

Mohamad E Allaf, MD

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).

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.

Prospective, single-institution, multi-surgeon, stratified randomized controlled trial. Randomization will be stratified into four groups by procedure approach (open or robotic) and whether patients elect to undergo a screening 30-day lower extremity Duplex (ultrasound or no ultrasound). Patients will then be randomized, within each of the strata, to the two arms (subcutaneous heparin versus no subcutaneous heparin).

PREvention of VENous ThromboEmbolism Following Radical Prostatectomy

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

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). The primary outcome is diagnosis of DVT or PE within 30 days after surgery due to imaging (any method, most commonly lower extremity ultrasound or computed tomography scan with pulmonary embolus protocol) prompted by symptoms of a DVT (lower extremity swelling, pain, fever of unknown origin) or PE (chest pain, shortness of breath, hypoxemia, tachycardia or fever of unknown origin, productive cough with bloody sputum).

This outcome is defined as a surgical or pelvic fluid collection diagnosed as a hematoma (blood collection, with or without infection) or lymphocele (collection of lymph fluid in the pelvis) due to symptoms (fever, abdominal pain, nausea or vomiting, anemia, high surgical drain output) within 30 days after surgery.

This additional primary outcome includes the development and diagnosis of any major clinically recognized bleeding event within 30 days after surgery requiring \>1 unit of packed red blood cell transfusion, intervention to stop bleeding, or return to the operating room.

DVT or PE diagnosed for any reason within 30 days after surgery. This includes any diagnosed DVT or PE as described in the primary outcome plus any additional DVTs or PEs diagnosed at 30 day screening lower extremity ultrasound for patients opting to undergo screening bilateral lower extremity Duplex ultrasound at 30 days who do not have symptoms.

The total recorded intraoperative estimated blood loss in milliliters reported at the end of the surgery.

The total output in milliliters from any surgical drain left in place (not all patients will necessarily have a surgical drain) after surgery and until discharge from the hospital (usually 1 to 2 days). Drain output, if one is left in place after discharge, will not count toward this secondary outcome.

Patients in each arm receiving postoperative diagnostic imaging for venous thromboembolism relative to symptoms (e.g. lower extremity Duplex ultrasound, spiral CT angiography, V/Q scan).

Johns Hopkins University

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.

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

Control

Total

Age, Continuous

Sex: Female, Male

White

African American

Hispanic

Asian

Race/Ethnicity, Customized

The study met a futility end point at the 2nd interim analysis (pre-planned in the study protocol) leading to an appropriate decision for early closure and termination rather than continuing to planned enrollment of N=666.

Dr. Mohamad Allaf

One participant in the control arm was lost to follow-up precluding outcome assessment.

Number of Participants With Symptomatic Venous Thromboembolism

Number of Participants With Symptomatic Postoperative Fluid Collection

Number of Participants With Major Postoperative Bleeding

Only the subset receiving ultrasound are analyzed for this outcome.

Number of Participants With Occurrence of Any Venous Thromboembolism

Estimated Blood Loss During Surgery

Surgical Drain Output After Surgery

Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms

Spots Global Cancer Trial Database for subcutaneous heparin