MUSC researchers receive PCORI grant to study safety, effectiveness of three blood-thinning drugs

Jan 5 2016

A research team at the Medical University of South Carolina has been approved for a $13.5 million funding award by the Patient-Centered Outcomes Research Institute (PCORI) to study the safety and effectiveness of three blood-thinning drugs used to prevent potentially deadly blood clots in patients undergoing hip and knee replacement. This is the first PCORI research funding award to MUSC serving as the lead center, with 25,000 patients and 25 centers nationwide involved in the study.

Vincent Pellegrini, M.D., the John A. Siegling Professor and chairman of the Department of Orthopaedics at the MUSC College of Medicine, is the lead investigator and was approved for the project titled, Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement (PEPPER): Balancing Safety and Effectiveness.

"We are excited to conduct this important study that will bring patients, their surgeons, and medical physicians together to provide important information about the benefits and harms related to anticoagulant drugs used to prevent blood clots after hip and knee replacement," Pellegrini said. "Despite other advances in joint replacement surgery, this issue has remained unresolved for nearly five decades. Our study will give a valuable voice to patients in determining an acceptable balance between the benefit of preventing pulmonary embolism and the risk of bleeding and reoperation while using blood thinning drugs after joint replacement surgery. The results of the trial have the potential to dramatically alter current practice the day the findings are released. We are grateful to PCORI for this opportunity."

Pellegrini's study was selected for funding through PCORI's Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a diverse range of patients and care situations and can be more quickly taken up in routine clinical practice. Pellegrini leads the joint replacement service at MUSC and is actively engaged in surgical practice. He and other faculty surgeons are accepting new patients with hip and knee arthritis who are considering joint replacement surgery and who may qualify for the study.

"This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders in a major study conducted in real-world settings, but also for its potential to answer an important question about preventing blood clots post-surgery and fill a crucial evidence gap," said PCORI Executive Director Joe Selby, M.D., MPH. "We look forward to following the study's progress and working with MUSC to share its results."

Many clinical studies test whether a treatment works under optimized conditions in specialized research centers, but health care is rarely delivered in such idealized situations and settings. Pragmatic clinical studies test a treatment's effectiveness in 'real-life' practice situations, such as typical hospitals and outpatient clinics, and also can include a wider range of study participants, making their findings more generally applicable.

MUSC's study was selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals.

"The awarding of this nationally competitive PCORI award to Dr. Pellegrini is strategically important for MUSC," said Mark Sothmann, Ph.D., MUSC vice president for academic affairs and provost. "It significantly advances our critical mission to put the patient's welfare first through cutting edge research." Pellegrini's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

Source: Medical University of South Carolina