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Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot (CRIT)

Primary Purpose

Myocardial Infarction, Anemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Packed Red Blood Cell Transfusion
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Anemia, Erythrocyte Transfusion

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All of the following must be present: Acute myocardial infarction with presentation within 72 hours of randomization (acute myocardial infarction is defined as ischemic-type chest discomfort lasting at least 30 minutes associated with creatinine kinase MB (CKMB) or troponin >upper limit of normal [ULN]) Admission to CCU Hematocrit .30 or less Written, informed consent Exclusion Criteria: Inability or unwillingness to receive red cell transfusions Active bleeding (overt blood loss accompanied by a decrease in hematocrit of at least 5% in the preceding 12 hours) Receipt of red cell transfusion within 7 days of randomization Prior severe transfusion reaction Pregnancy Imminent death Decision to provide limited care Age <21 Participation in another clinical trial in which blood transfusion is a requirement or a component of a primary or secondary endpoint Previous participation in the CRIT Pilot

Sites / Locations

  • Washington Hospital Center
  • Washington VA Medical Center
  • Durham VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Liberal transfusion threshold

Conservative transfusion threshold

Outcomes

Primary Outcome Measures

In-hospital death
Recurrent myocardial infarction (MI)
New or worsening heart failure

Secondary Outcome Measures

Critical Care Unit (CCU) length of stay
Length of hospitalization
Death or recurrent MI at hospital discharge and 30 days
Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days
Death at 30 days
In-hospital recurrent ischemia
In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia
Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL)
Number of transfusions received per patient
Proportion of patients receiving at least one transfusion
Mean daily hematocrit
Transfusion-related reactions

Full Information

First Posted
August 2, 2005
Last Updated
July 20, 2011
Sponsor
Medstar Health Research Institute
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00126334
Brief Title
Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot
Acronym
CRIT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medstar Health Research Institute
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.
Detailed Description
The current standard of care for patients with heart attacks is to transfuse red blood cells when the hematocrit (red blood cell count) drops below 30 percent. However, there is little scientific basis for this current standard, and recent research has demonstrated that it is safe to allow the hematocrit (red blood cell count) to drop significantly lower in severely ill medical patients and in patients with heart disease undergoing major surgery. The investigators therefore propose this pilot trial to begin to determine whether or not it is safe to apply a more conservative blood transfusion strategy to patients with heart attacks. In this study, patients who are within 72 hours of the onset of a heart attack and who are anemic (have a low red blood cell count) will be randomly assigned to one of two transfusion strategies while they are in the hospital: a liberal strategy of transfusing blood when the hematocrit falls below 30 percent (the current standard) or a conservative strategy of transfusing blood only when the hematocrit falls below 24 percent. It will then be determined which group fares better over the next 30 days. The plan is to enroll 92 patients in this pilot trial in order to allow the researchers to plan for a much larger, definitive trial of this important question. It is anticipated that the conservative transfusion strategy will be similar to the standard (liberal) strategy in terms of patient outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Anemia
Keywords
Myocardial Infarction, Anemia, Erythrocyte Transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Liberal transfusion threshold
Arm Title
2
Arm Type
Experimental
Arm Description
Conservative transfusion threshold
Intervention Type
Procedure
Intervention Name(s)
Packed Red Blood Cell Transfusion
Intervention Description
transfusion of 1 unit of PRBCs
Primary Outcome Measure Information:
Title
In-hospital death
Time Frame
In-hospital
Title
Recurrent myocardial infarction (MI)
Time Frame
In-hospital
Title
New or worsening heart failure
Time Frame
In-hospital
Secondary Outcome Measure Information:
Title
Critical Care Unit (CCU) length of stay
Time Frame
In-hospital
Title
Length of hospitalization
Time Frame
In-hospital
Title
Death or recurrent MI at hospital discharge and 30 days
Time Frame
30 days
Title
Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days
Time Frame
30 days
Title
Death at 30 days
Time Frame
30 days
Title
In-hospital recurrent ischemia
Time Frame
In-hospital
Title
In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia
Time Frame
In-hospital
Title
Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL)
Time Frame
In-hospitall
Title
Number of transfusions received per patient
Time Frame
In-hospital
Title
Proportion of patients receiving at least one transfusion
Time Frame
In-hospital
Title
Mean daily hematocrit
Time Frame
In-hospital
Title
Transfusion-related reactions
Time Frame
In-hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All of the following must be present: Acute myocardial infarction with presentation within 72 hours of randomization (acute myocardial infarction is defined as ischemic-type chest discomfort lasting at least 30 minutes associated with creatinine kinase MB (CKMB) or troponin >upper limit of normal [ULN]) Admission to CCU Hematocrit .30 or less Written, informed consent Exclusion Criteria: Inability or unwillingness to receive red cell transfusions Active bleeding (overt blood loss accompanied by a decrease in hematocrit of at least 5% in the preceding 12 hours) Receipt of red cell transfusion within 7 days of randomization Prior severe transfusion reaction Pregnancy Imminent death Decision to provide limited care Age <21 Participation in another clinical trial in which blood transfusion is a requirement or a component of a primary or secondary endpoint Previous participation in the CRIT Pilot
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard A Cooper, M.D.
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Washington VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34932836
Citation
Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
Results Reference
derived

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Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot

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