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Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia.

NCT02648113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2022-04-12

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Restrictive transfusion

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

PROCEDURE

Liberal transfusion

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

BIOLOGICAL

red blood transfusion

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Philippe-Gabriel STEG · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-23
Primary Completion
2019-10-10
Completion
2020-09-10

Countries

  • France
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648113 on ClinicalTrials.gov