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NCT02232568 · ClinicalTrials.gov registry record · NA
Trial of Feedback on Blood Use
A NA study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 426
- Enrollment target
NCT02232568 is a NA study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 426 participants.
The verdict
NCT02232568, a NA study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 426 participants
- Enrollment target
Study 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 surgeo
Interventions
- BEHAVIORAL Feedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2014-09-01 |
| Est. Completion | 2017-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02232568
The ClinicalTrials.gov registry entry for NCT02232568 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 426 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Feedback is the first listed.
NCT02232568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02232568 about?
NCT02232568 is a clinical study titled "Trial of Feedback on Blood Use". 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 ...
What is the current status of trial NCT02232568?
This trial is currently terminated. It is a NA study. The enrollment target is 426 participants. The study started on 2014-09-01. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT02232568?
The interventions under investigation include: Feedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT02232568?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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