CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 668 enrolled
Drug / intervention
red blood transfusion +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02648113
NCT02648113N/ACompleted

Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.

Assistance Publique - Hôpitaux de Paris·interventional·Posted Jan 6, 2016·Updated Apr 12, 2022

In Brief

A clinical study evaluating Restrictive transfusion, Liberal transfusion, and 1 other intervention for Myocardial Infarction and 2 related conditions. Completed, enrolled 668 participants across 2 sites in 2 countries.

Detailed Summary

Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there is an international consensus on the urgent need for a randomized trial. The investigators hypothesize that a "restrictive" transfusion strategy is at least non-inferior to a "liberal" transfusion strategy on 30-day outcomes of MI patients with anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility analysis becomes key to determining the role of each strategy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Spain
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 6, 2016
Enrollment StartMar 23, 2016
Primary CompletionOct 10, 2019
Study CompletionSep 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.5 years ago

Interventions

Restrictive transfusionprocedure

Transfusions are withheld unless Hb is \<= 8 g/dL, with a target Hb of 8 to 10 g /dL

Liberal transfusionprocedure

transfusions are allowed as soon as Hb \<= 10 g/dL with a target of 11 g /dL

red blood transfusionbiological