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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. (REALITY)

This study is currently recruiting participants.
Verified October 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02648113
First Posted: January 6, 2016
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention
Myocardial Infarction Anemia Blood Transfusion Procedure: Restrictive transfusion Procedure: Liberal transfusion Biological: red blood transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Cost-effectiveness ratio at 30 days [ Time Frame: 30 days ]
    The primary endpoint is the incremental cost-effectiveness ratio (ICER) at 30-days, using the composite endpoint (30-day composite of all-cause death, non fatal stroke, nonfatal recurrent MI, and emergency revascularization prompted by ischemia) as the effectiveness criterion


Secondary Outcome Measures:
  • Cost-effectiveness ratio at 1 year [ Time Frame: 1 year ]
    Incremental cost-effectiveness ratio (ICER) at 1 year, using the composite endpoint (1-year composite of all-cause death, non fatal stroke, nonfatal recurrent MI, and emergency revascularization prompted by ischemia) as the effectiveness criterion

  • Clinically non inferiority at 30 days [ Time Frame: 30 days ]
    The main clinical endpoint is Major Adverse Cardiac Events (MACE) at 30-days defined as the 30-day composite of all-cause death, non-fatal recurrent MI, non-fatal stroke and emergency revascularization prompted by ischemia, (all of the components of this composite clinical outcome will be analyzed separately as secondary endpoints of their own)

  • Clinically non inferiority at 1 year [ Time Frame: 1 year ]
    The main clinical endpoint is Major Adverse Cardiac Events (MACE) at 30-days defined as the 30-day composite of all-cause death, non-fatal recurrent MI, non-fatal stroke and emergency revascularization prompted by ischemia, (all of the components of this composite clinical outcome will be analyzed separately as secondary endpoints of their own)


Estimated Enrollment: 630
Study Start Date: March 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Restrictive transfusion strategy
Transfusions are withheld unless Hb is <= 8 g/dL, with a target Hb of 8 to 10 g /dL
Procedure: Restrictive transfusion
Transfusions are withheld unless Hb is <= 8 g/dL, with a target Hb of 8 to 10 g /dL
Biological: red blood transfusion
Experimental: Liberal transfusion strategy
Transfusions are allowed as soon as Hb <= 10 g/dL with a target of 11 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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years
  • Recent acute myocardial infarction, with or without ST- segment elevation, with a combination of ischemic symptoms occurring in the past 48 hours,before the MI related admission, and elevation of biomarkers of myocardial injury (troponin)
  • Anemia Hb ≤ 10g / dL but > 7 g/dL on Hb, measured at any time during the index hospital admission for MI.
  • Written informed consent
  • Coverage for medical insurance.

Exclusion Criteria:

  • Shock (SBP < 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
  • MI occurring post-percutaneous coronary intervention (PCI) or post-coronary artery bypass graft (CABG) (i.e. type IV or V Acute MI according to the 2012 Universal Definition of MI
  • Life-threatening or massive ongoing bleeding (as judged by the investigator)
  • Any blood transfusion in the previous 30-days
  • any known malignant hematologic disease Note: Sickle cell disease, thalassemia and anemia due to chronic renal failure (even under EPO) are not an exclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648113


Contacts
Contact: Philippe-Gabriel STEG gabriel.steg@aphp.fr
Contact: Grégory DUCROCQ gregory.ducrocq@aphp.fr

Locations
France
Hôpital Bichat Recruiting
Paris, France
Contact: Philippe-Gabriel STEG       gabriel.steg@aphp.fr   
Contact: Grégory DUCROCQ       gregory.ducrocq@aphp.fr   
Principal Investigator: Grégory DUCROCQ         
Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Gonzalo CALVO, Pr       GCALVO@clinic.cat   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe-Gabriel STEG Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02648113     History of Changes
Other Study ID Numbers: K140705
2015-A00360-49 ( Other Identifier: ANSM )
First Submitted: January 5, 2016
First Posted: January 6, 2016
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myocardial Infarction
Anemia
Blood Transfusion

Additional relevant MeSH terms:
Anemia
Infarction
Myocardial Infarction
Hematologic Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases