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Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Kevin Perry, M.D.

Abierto para la inscripción

Contact information:

Teron Cox CCRP

(507) 538-3560

Cox.Teron@mayo.edu

More information

Publicaciones

  • More than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%-0.5% fatal PE, and over 1000 deaths. Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications. Read More on PubMed

Otros temas en investigación

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CLS-20492217

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