Back to resultsComparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement (PEPPER)
Primary Purpose
Pulmonary Embolism, Venous Thrombosis
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Enteric Coated Aspirin
Warfarin
Rivaroxaban
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Embolism focused on measuring Anticoagulant, Venous Thromboembolism, Pulmonary Embolism, Total Knee Arthroplasty, Total Hip Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- 21 years of age or older;
- Undergoing elective primary, revision or second stage re-implantation total hip/knee replacement or uni-compartmental knee replacement or hip resurfacing arthroplasty;
- Has necessary mental capacity to participate and is able to comply with study protocol requirements;
- Eligible for randomization to at least two of the three study regimens;
- Is not pregnant on the day of surgery;
- Has signed the consent form; and
- Is willing to be randomized and participate in the study.
Exclusion Criteria:
- Undergoing bilateral hip or knee replacement;
- Has been previously enrolled;
- Is pregnant or breastfeeding;
- Is on chronic anticoagulation other than antiplatelet medications;
- Concurrently enrolled in another active interventional clinical trial testing a drug or intervention known or believed to interact with aspirin, warfarin, or rivaroxaban;
- Has documented gastrointestinal, cerebral, or other hemorrhage within 3 months;
- Has a known diagnosis of defective hemostasis and past history of clinical bleeding requiring transfusion and treatment;
- Has had an operative procedure involving the eye, ear, or central nervous system within one month;
- Has uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg;
- Body weight of less than 41 kilograms at baseline visit;
- Member of a vulnerable patient population.
Sites / Locations
- Mayo ClinicRecruiting
- University of Arkansas for Medical Sciences
- UCLA
- Stanford University HospitalRecruiting
- Arthritis Surgery Research Foundation
- Rush University Medical Center
- Indiana University
- Sinai HospitalRecruiting
- Johns Hopkins UniversityRecruiting
- Brigham & Women's HospitalRecruiting
- Boston University Medical CenterRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Lahey ClinicRecruiting
- Mayo ClinicRecruiting
- University of Nebraska Medical CenterRecruiting
- Dartmouth-Hitchcock Medical CenterRecruiting
- New York University
- Northwell HealthRecruiting
- Duke University Medical Center
- Cleveland ClinicRecruiting
- Penn State Hershey Med Center
- University of PennsylvaniaRecruiting
- Lifespan HealthRecruiting
- Medical University of South CarolinaRecruiting
- Anderson Orthopaedic Institute (VA)
- University of VirginiaRecruiting
- Virginia Commonwealth University Medical CenterRecruiting
- University of WashingtonRecruiting
- West Virginia UniversityRecruiting
- London Health Sciences CentreRecruiting
- University of OttawaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1: Enteric Coated Aspirin
Arm 2: Warfarin Other Names: Coumadin
Arm 3: Rivaroxaban Other Names: Xarelto
Arm Description
Enteric coated aspirin (162 mg po) will be administered on the day of operation, prior to surgery, with a sip of water. Thereafter, starting on postoperative day #1, all patients in the aspirin group will receive 81 mg po bid to complete the treatment period of 30 days. Patients on preoperative cardiac dose aspirin may continue their usual dosing regimen prior to the morning of surgery, and then commence the PEPPER trial aspirin dose of 81 mg po bid on the day after operation.
Warfarin will be administered starting on the day of operation, prior to surgery, with a sip of water. The initial dose will be empirically determined by body weight: less than 125 lbs (56.7 kg) - 2.5 mg; 125-250 lbs (56.7-113.4 kg) - 5 mg; greater than 250 lbs (113.4 kg) - 7.5mg. The initial dose will be repeated on the evening of surgery if the preoperative dose was administered prior to noon on the day of operation; no warfarin will be given on the evening of surgery if the preoperative dose was received after noon on the day of operation. Thereafter, starting on postoperative day #1, warfarin will be given each evening based on INR values to achieve a target of 2.0 (range 1.7-2.2).
Rivaroxaban 10 mg will be first administered approximately 24 hours after completion of the index operation. Medication will then be administered in the evening on postoperative day #2 and thereafter each evening until completion.
Outcomes
Primary Outcome Measures
Aggregate primary clinical endpoints of all-cause mortality plus PE and DVT
To compare the frequency of the aggregate primary clinical endpoints of important venous thromboembolism (clinical PE and DVT leading to hospital readmission) and all-cause mortality (aggregate indicator of fatal events, including both PE and major hemorrhage related to anticoagulant use) among three different venous thromboembolism (VTE) prophylaxis regimens. An audit of all hospital readmissions within 6 months of operation will be accomplished by routine postoperative follow-up through a mechanism of central telephone surveillance of patient-reported outcome events that is augmented by on-site research coordinator follow-up and validation of suspected endpoint events and adverse outcomes.
The frequency and nature of bleeding complications
To compare the frequency and nature of bleeding complications (major, clinically important, and wound-related) leading to wound drainage, reoperation, or deep infection, or myocardial infarction among three different VTE prophylaxis regimens.
Specific Joint Function
To compare the groups with respect to patient-reported outcomes in order to assess their impact on specific function of the replaced joint. Validated functional outcome tools will be compared among patients with and without primary endpoint events, as well as with historical baseline data warehoused in the FORCE registry, a national Agency for Healthcare Research and Quality (AHRQ) funded joint replacement outcomes database. Study site overlap with the FORCE registry is planned.
Patient Well- Being
To compare the groups with respect to patient-reported outcomes in order to assess their impact on general patient well-being. Validated functional outcome tools will be compared among patients with and without primary endpoint events, as well as with historical baseline data warehoused in the FORCE registry, a national AHRQ funded joint replacement outcomes database. Study site overlap with the FORCE registry is planned.
Secondary Outcome Measures
"Standard of care" methods of anesthesia on clinical effectiveness of three different prophylaxis regimens based on adverse events
Analysis of the contribution of "standard of care" methods of anesthesia on clinical effectiveness of three different prophylaxis regimens. Stratification and subgroup analysis between patients with general compared with regional neuraxial (spinal/epidural) anesthesia will assess contribution of anesthesia to efficacy of VTE prophylaxis.
Comparative frequency of thromboembolic events and bleeding complications occurring after hip and knee replacement
Analysis of the the relative frequency of thromboembolic events and bleeding complications in total hip compared with knee replacement patients. Evidence suggests etiology of venous thromboembolic disease (VTED) differs between THA and TKA and each may warrant a distinctive prophylaxis regimen based on likely outcomes.
Full Information
NCT ID
NCT02810704
First Posted
May 11, 2016
Last Updated
November 3, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, University of Maryland, Baltimore, Brigham and Women's Hospital, Northwestern University, Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02810704
Brief Title
Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement
Acronym
PEPPER
Official Title
Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement: Balancing Safety and Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, University of Maryland, Baltimore, Brigham and Women's Hospital, Northwestern University, Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
PEPPER is a large pragmatic clinical trial to inform patient choice and balance risk tolerances of individuals who face decisions about different drugs and strategies for deep vein thrombosis (DVT) and pulmonary embolism (PE) prevention after total hip (THA) and knee (TKA) replacement. Indeed, clinical equipoise exists to ethically support such a randomized trial that has great potential to change current practice. We have selected the three prophylaxis methods that represent current orthopaedic practice in North America and collectively account for more than 80% of all hip and knee replacements; a) enteric coated aspirin (regimen with lowest bleeding risk; clinical PE and all-cause mortality rates comparable to more intensive anticoagulants), b) low intensity (INR Target 2.0) warfarin (time honored and one of the most common North American regimens; low bleeding risk [1-2%]), and c) rivaroxaban, a new oral direct Factor Xa inhibitor (regimen with lowest PE and DVT rate but higher bleeding risk [3-5%]). Prophylaxis will continue for 30 days, in accordance with clinical guidelines, and pneumatic compression will be utilized in hospital in conjunction with each treatment group. Each regimen is commonly used in contemporary practice, supported by observational and clinical trial data, and endorsed by the American College of Chest Physicians (ACCP) and American Academy of Orthopaedic Surgeons (AAOS) guidelines
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Venous Thrombosis
Keywords
Anticoagulant, Venous Thromboembolism, Pulmonary Embolism, Total Knee Arthroplasty, Total Hip Arthroplasty
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Enteric Coated Aspirin
Arm Type
Experimental
Arm Description
Enteric coated aspirin (162 mg po) will be administered on the day of operation, prior to surgery, with a sip of water. Thereafter, starting on postoperative day #1, all patients in the aspirin group will receive 81 mg po bid to complete the treatment period of 30 days. Patients on preoperative cardiac dose aspirin may continue their usual dosing regimen prior to the morning of surgery, and then commence the PEPPER trial aspirin dose of 81 mg po bid on the day after operation.
Arm Title
Arm 2: Warfarin Other Names: Coumadin
Arm Type
Experimental
Arm Description
Warfarin will be administered starting on the day of operation, prior to surgery, with a sip of water. The initial dose will be empirically determined by body weight: less than 125 lbs (56.7 kg) - 2.5 mg; 125-250 lbs (56.7-113.4 kg) - 5 mg; greater than 250 lbs (113.4 kg) - 7.5mg. The initial dose will be repeated on the evening of surgery if the preoperative dose was administered prior to noon on the day of operation; no warfarin will be given on the evening of surgery if the preoperative dose was received after noon on the day of operation. Thereafter, starting on postoperative day #1, warfarin will be given each evening based on INR values to achieve a target of 2.0 (range 1.7-2.2).
Arm Title
Arm 3: Rivaroxaban Other Names: Xarelto
Arm Type
Experimental
Arm Description
Rivaroxaban 10 mg will be first administered approximately 24 hours after completion of the index operation. Medication will then be administered in the evening on postoperative day #2 and thereafter each evening until completion.
Intervention Type
Drug
Intervention Name(s)
Enteric Coated Aspirin
Other Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Primary Outcome Measure Information:
Title
Aggregate primary clinical endpoints of all-cause mortality plus PE and DVT
Description
To compare the frequency of the aggregate primary clinical endpoints of important venous thromboembolism (clinical PE and DVT leading to hospital readmission) and all-cause mortality (aggregate indicator of fatal events, including both PE and major hemorrhage related to anticoagulant use) among three different venous thromboembolism (VTE) prophylaxis regimens. An audit of all hospital readmissions within 6 months of operation will be accomplished by routine postoperative follow-up through a mechanism of central telephone surveillance of patient-reported outcome events that is augmented by on-site research coordinator follow-up and validation of suspected endpoint events and adverse outcomes.
Time Frame
Within 6 months of operation
Title
The frequency and nature of bleeding complications
Description
To compare the frequency and nature of bleeding complications (major, clinically important, and wound-related) leading to wound drainage, reoperation, or deep infection, or myocardial infarction among three different VTE prophylaxis regimens.
Time Frame
Within 6 months of operation
Title
Specific Joint Function
Description
To compare the groups with respect to patient-reported outcomes in order to assess their impact on specific function of the replaced joint. Validated functional outcome tools will be compared among patients with and without primary endpoint events, as well as with historical baseline data warehoused in the FORCE registry, a national Agency for Healthcare Research and Quality (AHRQ) funded joint replacement outcomes database. Study site overlap with the FORCE registry is planned.
Time Frame
Within 6 months of operation
Title
Patient Well- Being
Description
To compare the groups with respect to patient-reported outcomes in order to assess their impact on general patient well-being. Validated functional outcome tools will be compared among patients with and without primary endpoint events, as well as with historical baseline data warehoused in the FORCE registry, a national AHRQ funded joint replacement outcomes database. Study site overlap with the FORCE registry is planned.
Time Frame
Within 6 months of operation
Secondary Outcome Measure Information:
Title
"Standard of care" methods of anesthesia on clinical effectiveness of three different prophylaxis regimens based on adverse events
Description
Analysis of the contribution of "standard of care" methods of anesthesia on clinical effectiveness of three different prophylaxis regimens. Stratification and subgroup analysis between patients with general compared with regional neuraxial (spinal/epidural) anesthesia will assess contribution of anesthesia to efficacy of VTE prophylaxis.
Time Frame
Within 6 months of operation
Title
Comparative frequency of thromboembolic events and bleeding complications occurring after hip and knee replacement
Description
Analysis of the the relative frequency of thromboembolic events and bleeding complications in total hip compared with knee replacement patients. Evidence suggests etiology of venous thromboembolic disease (VTED) differs between THA and TKA and each may warrant a distinctive prophylaxis regimen based on likely outcomes.
Time Frame
Within 6 months of operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
21 years of age or older;
Undergoing elective primary, revision or second stage re-implantation total hip/knee replacement or uni-compartmental knee replacement or hip resurfacing arthroplasty;
Has necessary mental capacity to participate and is able to comply with study protocol requirements;
Eligible for randomization to at least two of the three study regimens;
Is not pregnant on the day of surgery;
Has signed the consent form; and
Is willing to be randomized and participate in the study.
Exclusion Criteria:
Undergoing bilateral hip or knee replacement;
Has been previously enrolled;
Is pregnant or breastfeeding;
Is on chronic anticoagulation other than antiplatelet medications;
Concurrently enrolled in another active interventional clinical trial testing a drug or intervention known or believed to interact with aspirin, warfarin, or rivaroxaban;
Has documented gastrointestinal, cerebral, or other hemorrhage within 3 months;
Has a known diagnosis of defective hemostasis and past history of clinical bleeding requiring transfusion and treatment;
Has had an operative procedure involving the eye, ear, or central nervous system within one month;
Has uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg;
Body weight of less than 41 kilograms at baseline visit;
Member of a vulnerable patient population.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol A Lambourne, PhD
Phone
603-308-9128
Email
carol.a.lambourne@hitchcock.org
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Baczko, MPA
Phone
843-792-8169
Email
baczko@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent D Pellegrini, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol A Lambourne, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Spangehl, MD
Email
spangehl.mark@mayo.edu
First Name & Middle Initial & Last Name & Degree
Mark Spangehl, MD
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Terminated
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Terminated
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Maloney
Email
wmaloney@stanford.edu
First Name & Middle Initial & Last Name & Degree
William Maloney, MD
Facility Name
Arthritis Surgery Research Foundation
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Terminated
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Terminated
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46037
Country
United States
Individual Site Status
Terminated
Facility Name
Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Nace, MD
Email
Jnace@lifebridgehealth.org
First Name & Middle Initial & Last Name & Degree
James Nace, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sterling, MD
Email
rsterli6@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Robert Sterling, MD
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Jordan
Email
ejordan6@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Richard Iorio, MD
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kain, MD
Email
michael.kain@bmc.org
First Name & Middle Initial & Last Name & Degree
Michael Kain, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Drew, MD
Email
jdrew@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jacob Drew, MD
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Specht, MD
Email
Lawrence.M.Specht@lahey.org
First Name & Middle Initial & Last Name & Degree
Lawrence Specht, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Perry, MD
Email
perry.kevin@mayo.edu
First Name & Middle Initial & Last Name & Degree
Kevin Perry, MD
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Garvin, MD
Email
kgarvin@unmc.edu
First Name & Middle Initial & Last Name & Degree
Kevin Garvin, MD
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Symonds
Email
Holly.B.Symonds@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Wayne Moschetti, MD
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Terminated
Facility Name
Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Oh, MD
Email
joh6@northwell.edu
First Name & Middle Initial & Last Name & Degree
Jason Oh, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Terminated
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Molloy, MD
Email
molloyr@ccf.org
First Name & Middle Initial & Last Name & Degree
Robert Malloy, MD
Facility Name
Penn State Hershey Med Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Terminated
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Nelson, MD
Email
Charles.Nelson@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Charles L Nelson, MD
Facility Name
Lifespan Health
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Cohen, MD
Email
ecohen@universityorthopedics.com
First Name & Middle Initial & Last Name & Degree
Eric Cohen, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Baczko, MPA
Email
baczko@musc.edu
First Name & Middle Initial & Last Name & Degree
Zeke Walton, MD
Facility Name
Anderson Orthopaedic Institute (VA)
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States
Individual Site Status
Terminated
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric McVey
Email
emcvey@virginia.edu
First Name & Middle Initial & Last Name & Degree
James Browne, MD
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Morgan
Email
melanie.morgan@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Stephen Kates, MD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Chancellor
Email
achance@uw.edu
First Name & Middle Initial & Last Name & Degree
Navin D Fernando, MD
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Eicher
Email
jeicher@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Brock Lindsey, MD
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Allen
Email
abbigail.allen@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Brent Lanting, MD
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meaghan Dufresne
Email
meadufresne@ohri.ca
First Name & Middle Initial & Last Name & Degree
Paul Beaule, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The participating institutions will follow NIH guidelines concerning the sharing of research data. As outlined by the NIH and Patient-Centered Outcomes Research Institute (PCORI), the participating institutions will make available to the public the results of this collaboration and any accompanying data that were supported by PCORI. There are no specimens or biological resources for sharing as a result of this planned project.
In the course of this research project, we anticipate generating ranges of estimated complications and adverse events as they relate to the use of VTE prophylaxis in the context of hip and knee replacement. Access to these data and associated recommendations generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate and consistent with the data distribution policies of the Medical University of South Carolina and the University of Maryland.
IPD Sharing Time Frame
Spring 2024
IPD Sharing Access Criteria
to be determined
Citations:
PubMed Identifier
31895235
Citation
Pellegrini VD Jr, Eikelboom J, McCollister Evarts C, Franklin PD, Goldhaber SZ, Iorio R, Lambourne CA, Magaziner JS, Magder LS; Steering Committee of The PEPPER Trial. Selection Bias, Orthopaedic Style: Knowing What We Don't Know About Aspirin. J Bone Joint Surg Am. 2020 Apr 1;102(7):631-633. doi: 10.2106/JBJS.19.01135. No abstract available.
Results Reference
background
PubMed Identifier
36303136
Citation
Ko H, Pelt CE, Martin BI; PEPPER Investigators; Pellegrini VD Jr. Patient-reported outcomes following cemented versus cementless primary total knee arthroplasty: a comparative analysis based on propensity score matching. BMC Musculoskelet Disord. 2022 Oct 27;23(1):934. doi: 10.1186/s12891-022-05899-1.
Results Reference
derived
PubMed Identifier
35260464
Citation
Pellegrini VD Jr, Eikelboom JW, Evarts CM, Franklin PD, Garvin KL, Goldhaber SZ, Iorio R, Lambourne CA, Magaziner J, Magder L; Steering Committee of the PEPPER Trial and the PEPPER Trial Investigators, funded by PCORI. Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol. BMJ Open. 2022 Mar 8;12(3):e060000. doi: 10.1136/bmjopen-2021-060000.
Results Reference
derived
PubMed Identifier
31926776
Citation
Finch DJ, Martin BI, Franklin PD, Magder LS, Pellegrini VD Jr; PEPPER Investigators. Patient-Reported Outcomes Following Total Hip Arthroplasty: A Multicenter Comparison Based on Surgical Approaches. J Arthroplasty. 2020 Apr;35(4):1029-1035.e3. doi: 10.1016/j.arth.2019.10.017. Epub 2019 Oct 17.
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Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement
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