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Trial of Feedback on Blood Use (TOFU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02232568
Recruitment Status : Terminated (Insufficient numbers of participating sites and hip surgery cases.)
First Posted : September 5, 2014
Last Update Posted : May 18, 2020
Information provided by (Responsible Party):
Kaufman, Richard Max,M.D., Brigham and Women's Hospital

Brief Summary:

Trial of Feedback on Blood Use (TOFU)

The TOFU study will represent the first attempt to rigorously assess the impact of audit-feedback on changing transfusion practice. The primary hypothesis is that providing individual feedback on transfusion practice to orthopedic surgeons will reduce elective RBC transfusions in the postoperative period.

TOFU is a two-arm, cluster-randomized controlled trial. Initially, baseline blood use data will be collected at all study sites. Next, the PI at each site will give a short educational presentation to the orthopedic surgeons. The presentation will consist of a standardized 10-minute presentation reviewing the data from the FOCUS trial and the recommended red blood cell (RBC) transfusion trigger of 8 g/dL (or symptomatic anemia) based on that data. Clusters of orthopedic surgeons will then be randomized to either the Control arm (no feedback) or the Intervention arm (monthly feedback). All of the surgeons at a given site will either receive or not receive feedback. The feedback will take the form of emailed monthly reports detailing blood use by each surgeon post-hip surgery. Surgeons will be anonymized in the reports as "A, B, C . . ." but each surgeon will know which data are his own. The primary end point is the decrease from baseline in the proportion of patients transfused with a pretransfusion hemoglobin of > 8 g/dL.

TOFU will be conducted at 8 sites in Europe and North and South America. Care has been taken to minimize the labor and costs required to conduct this study. The only data collected will be: patient age/gender; procedure; surgeon (anonymized); surgery & discharge dates; RBC units transfused; Hgb levels. The data will be entered at each site into a web-based Case Report Form, and will be stored centrally by the Data Coordinating Center (DCC). The DCC will generate monthly feedback reports and email them to each Intervention arm site PI. The site PI will then email the reports to each local orthopedic surgeon.

Condition or disease Intervention/treatment Phase
Compliance With Restrictive RBC Transfusion Guideline Behavioral: Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Trial of Feedback on Blood Use
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Feedback Arm
Orthopedic surgeons in the Feedback Arm will receive monthly reports providing individualized data on compliance with the FOCUS trial RBC transfusion guideline (pretransfusion Hb <8 g/dL for hip surgery patients in the postoperative period.) Feedback data will be anonymized, but surgeons will be able to see their own data in comparison with their peers.
Behavioral: Feedback
No Intervention: Control Arm
Orthopedic surgeons in the Control Arm will not receive any feedback on their use of RBC transfusion in hip surgery patients.

Primary Outcome Measures :
  1. Proportion of patients transfused [ Time Frame: 12 months ]
    Decrease from baseline in the proportion of patients transfused with pretransfusion hemoglobin of > 8 g/dL.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients >= 18 years old undergoing total hip arthroplasty or hip hemiarthroplasty

Exclusion Criteria:

  • Refusal of blood transfusions
  • Surgeons utilizing "fast track" protocols (planned discharge on postoperative day 1 or 2 following surgery.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02232568

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United States, Massachusetts
Richard Kaufman MD
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Ronald Jackups MD, PhD
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Richard M Kaufman, MD Brigham and Women's Hospital
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Responsible Party: Kaufman, Richard Max,M.D., Medical Director, Adult Transfusion Service, Brigham and Women's Hospital Identifier: NCT02232568    
Other Study ID Numbers: 2013P001165
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaufman, Richard Max,M.D., Brigham and Women's Hospital:
Patient blood management
RBC transfusion
Restrictive transfusion strategy