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NCT02648113: REALITY

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

Completed NA Last updated 12 April 2022
What this trial tests

NA trial testing Restrictive transfusion in Myocardial Infarction in 668 participants. Completed in 10 September 2020.

Timeline
23 March 2016
Primary endpoint
10 October 2019
10 September 2020

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment668
Start date23 March 2016
Primary completion10 October 2019
Estimated completion10 September 2020
Sites2 locations across France, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Myocardial Infarction or Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion.
    Carson JL, Stanworth SJ, Roubinian N, Fergusson DA, et al · · 2016 · cited 232× · PMID 27731885 · DOI 10.1002/14651858.cd002042.pub4
  2. Effect of a Restrictive vs Liberal Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Clinical Trial.
    Ducrocq G, Gonzalez-Juanatey JR, Puymirat E, Lemesle G, et al · · 2021 · cited 183× · PMID 33560322 · DOI 10.1001/jama.2021.0135
  3. Transfusion thresholds for guiding red blood cell transfusion.
    Carson JL, Stanworth SJ, Dennis JA, Trivella M, et al · · 2021 · cited 165× · PMID 34932836 · DOI 10.1002/14651858.cd002042.pub5
  4. Transfusion strategies in non-bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.
    Vlaar AP, Oczkowski S, de Bruin S, Wijnberge M, et al · · 2020 · cited 160× · PMID 31912207 · DOI 10.1007/s00134-019-05884-8
  5. Management and prevention of anemia (acute bleeding excluded) in adult critical care patients.
    Lasocki S, Pène F, Ait-Oufella H, Aubron C, et al · · 2020 · cited 35× · PMID 32700082 · DOI 10.1186/s13613-020-00711-6
  6. Economic evaluation of restrictive vs. liberal transfusion strategy following acute myocardial infarction (REALITY): trial-based cost-effectiveness and cost-utility analyses.
    Durand-Zaleski I, Ducrocq G, Mimouni M, Frenkiel J, et al · · 2023 · cited 10× · PMID 35612990 · DOI 10.1093/ehjqcco/qcac029
  7. Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: Rationale and design of the REALITY trial.
    Ducrocq G, Calvo G, González-Juanatey JR, Durand-Zaleski I, et al · · 2021 · cited 9× · PMID 33405291 · DOI 10.1002/clc.23453
  8. 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

Verify or expand the search:

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing