Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

Overview

About this study

PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Males and females 21 years of age or older
  2. Undergoing elective primary or revision hip or knee replacement
  3. Patient has necessary mental capacity to participate and is able to comply with study protocol requirements
  4. Patient has signed study-specific informed consent form and agrees to randomization

Exclusion Criteria:

  1. No patient undergoing total hip or knee replacement who has been enrolled in this study for a prior hip or knee replacement can be enrolled for a second hip or knee replacement in this study.
  2. Women who are pregnant or breastfeeding, as well as those of reproductive potential unless there is a negative urine pregnancy test.
  3. A preoperative need for chronic anticoagulation other than with antiplatelet medications
  4. A known condition of thrombophilia proven by diagnostic laboratory testing
  5. Documented gastrointestinal, cerebral, or other hemorrhage within 3 months of the operation
  6. A known hypersensitivity to heparin
  7. A known diagnosis of defective hemostasis such as hemophilia
  8. A bleeding event within one month of an operative procedure involving the eye, ear, or central nervous system
  9. Severe uncontrolled hypertension with systolic BP > 220mmHg and diastolic BP > 120mmHg
  10. An absolute body weight of less than 41 kilograms (90.4 lbs) on day of enrollment
  11. Vulnerable patient populations including prisoners, minors under age 21, institutionalized individuals, and those who are mentally handicapped

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kevin Perry, M.D.

Open for enrollment

Contact information:

Teron Cox CCRP

(507) 538-3560

Cox.Teron@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20492217

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