PREvention of VENous ThromboEmbolism Following Radical Prostatectomy

NCT03006562 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00123618
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Symptomatic Venous Thromboembolism

  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).

  30 days

• Number of Participants With Symptomatic Postoperative Fluid Collection

  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.

  30 days

• Number of Participants With Major Postoperative Bleeding

  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.

  30 days

Secondary Outcomes (4)

• Number of Participants With Occurrence of Any Venous Thromboembolism

  30 days

• Estimated Blood Loss During Surgery

  During surgery (usually between 2-3 hours of operative time)

• Surgical Drain Output After Surgery

  Over length of stay in hospital (usually 1 to 2 days)

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

  30 days

Study Arms (2)

Subcutaneous Heparin

EXPERIMENTAL

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.

Drug: Subcutaneous Heparin

Control

NO INTERVENTION

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

Interventions

Subcutaneous Heparin DRUG

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

Subcutaneous Heparin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• Huang 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 BACKGROUND

• Patel 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 RESULT

• Patel 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 DERIVED

• Patel 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Mohamad Allaf
• Organization: Johns Hopkins Brady Urological Institute

mallaf@jhmi.edu

410-955-6100

Study Officials

• Mohamad E Allaf, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: July 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 5, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)