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  • Research & Results
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  • Comparing Medicines to Prevent Blood ...

Comparing Medicines to Prevent Blood Clots in Patients Who Have Hip or Knee Replacement Surgery -- The PEPPER Study

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Project Summary  

PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Nearly 1 million hip replacement and knee replacement surgeries take place in the United States each year. A small number of patients develop blood clots in their lungs or legs. These clots cause between 1,000 and 5,000 deaths each year. Medicines called blood thinners can lower a person’s risk of forming a blood clot after surgery. But blood thinners can also raise the chance of serious or uncontrolled bleeding. Bleeding problems can cause pain and stiffness or affect how well a replaced joint works. Bleeding problems can also cause an infection that may require surgery to remove the replaced hip or knee joint.

Doctors don’t know how best to balance preventing blood clots against the chance of bleeding problems in patients who have hip or knee replacement surgery. Previous studies have shown that different blood thinners carry different risks of causing bleeding problems. Some guidelines recommend using strong blood thinners after knee or hip replacement surgery; others recommend weaker ones because of the chance of bleeding.

Because it’s so uncommon for a patient to die from a blood clot after hip or knee replacement surgery, earlier studies didn’t have enough patients to help researchers identify which blood thinners work best to save lives. This study is large enough to compare differences in the rates of blood clots and mortality after hip and knee replacement surgery among the three most commonly used blood thinners; the study is also comparing the medicines’ chances of causing bleeding problems.

Who can this research help?

Information from this study can help people who have hip or knee replacement surgery and their doctors choose a medicine to prevent blood clots.

What is the research team doing?

The research team is recruiting 25,000 patients who are having hip or knee replacement surgery at one of 25 medical centers across the United States. The team is assigning patients by chance to get one of three medicines that are commonly used to prevent blood clots after surgery.

The research team is comparing how many patients in each of the three groups

  • Have bleeding problems
  • Return to the hospital because of a blood clot in their leg or lung
  • Die, even if their death is not related to a blood clot

The research team formed a patient advisory board of people who had had hip or knee replacement surgery. The board includes people who had problems after surgery. The board is helping the research team to understand patients’ views on the benefits and harms of blood thinners.

Research methods at a glance

Design Element Description
Study Design Randomized controlled trial
Population Adults aged 21 years and older who are having hip or knee replacement surgery
Interventions/
Comparators
  • Enteric-coated aspirin
  • Low-intensity warfarin
  • Rivaroxaban
Outcomes

Death from any cause, hospital readmission because of a blood clot in the leg or lung, bleeding complications, functioning of the hip or knee joint, patient well-being

Timeframe 6-month follow-up for study outcomes

Related Articles

The Journal of Bone & Joint Surgery

Selection Bias, Orthopaedic Style: Knowing What We Don't Know About Aspirin

The Journal of Arthroplasty

The Effects of Bundled Payment Programs for Hip and Knee Arthroplasty on Patient-Reported Outcomes

The Journal of Arthroplasty

Patient-reported Outcomes Following Total Hip Arthroplasty: A Multicenter Comparison Based on Surgical Approaches

Project Details

Principal Investigator
Vincent Domenic Pellegrini, MD
Project Status
In progress; Recruiting
Project Title
Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement (PEPPER): Balancing Safety and Effectiveness
Board Approval Date
August 2015
Project End Date
July 2024
Organization
Dartmouth-Hitchcock Clinic^
Year Awarded
2015
State
New Hampshire
Project Type
Research Project
Health Conditions  
Cardiovascular Diseases
Deep Vein Thrombosis/Pulmonary Embolism
Muscular and Skeletal Disorders
Arthritis
Joint Replacement
Intervention Strategies
Device Interventions
Drug Interventions
Populations
Individuals with Multiple Chronic/co-morbid Conditions
Low Income
Older Adults
Racial/Ethnic Minorities
Rural
Urban
Funding Announcement
Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes
Project Budget
$14,355,341
Study Registration Information
HSRP20162189
NCT02810704

^This project was based at the Medical University of South Carolina when it was awarded.

Page Last Updated: 
February 20, 2020

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Meetings & Events

March 2
Cycle 1 2021 PCORnet Phase 3 Applicant Town Hall
March 8
Engagement Awards 2021 Special Cycle -- Applicant Office Hours (One)
March 15
Priorities on the Health Horizon: Informing PCORI's Strategic Plan (Webinar)

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Research Institute

1828 L Street, NW, Suite 900
Washington, DC 20036
Phone: (202) 827-7700 | Fax: (202) 355-9558
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