NCT02232568: TOFU

Trial of Feedback on Blood Use

Terminated NA Last updated 18 May 2020

What this trial tests

NA trial testing Feedback in Compliance With Restrictive RBC Transfusion Guideline in 426 participants. Terminated before completion.

Timeline

1 September 2014

Primary endpoint
1 February 2017

1 November 2017

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	426
Start date	1 September 2014
Primary completion	1 February 2017
Estimated completion	1 November 2017
Sites	5 locations across United States

Drugs / interventions tested

• Feedback

Conditions studied

• Compliance With Restrictive RBC Transfusion Guideline — all drugs for Compliance With Restrictive RBC Transfusion Guideline →

Sponsor

Brigham and Women's Hospital

Who can join

Eligibility, any sex, with Compliance With Restrictive RBC Transfusion Guideline. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support.
   Radford M, Estcourt LJ, Sirotich E, Pitre T, et al · · 2024 · cited 8× · PMID 38780066 · DOI 10.1002/14651858.cd011305.pub3