NCT00126334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

7.7 years

First QC Date

August 2, 2005

Last Update Submit

July 20, 2011

Conditions

Myocardial InfarctionAnemia

Keywords

Myocardial InfarctionAnemiaErythrocyte Transfusion

Outcome Measures

Primary Outcomes (3)

  • In-hospital death

    In-hospital

  • Recurrent myocardial infarction (MI)

    In-hospital

  • New or worsening heart failure

    In-hospital

Secondary Outcomes (12)

  • Critical Care Unit (CCU) length of stay

    In-hospital

  • Length of hospitalization

    In-hospital

  • Death or recurrent MI at hospital discharge and 30 days

    30 days

  • Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days

    30 days

  • Death at 30 days

    30 days

  • +7 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Liberal transfusion threshold

Procedure: Packed Red Blood Cell Transfusion

2

EXPERIMENTAL

Conservative transfusion threshold

Procedure: Packed Red Blood Cell Transfusion

Interventions

Packed Red Blood Cell TransfusionPROCEDURE

transfusion of 1 unit of PRBCs

12

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Washington VA Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Durham VA Medical Center

Durham, North Carolina, United States

Location

Related Publications (2)

  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • 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.

    PMID: 34932836DERIVED

MeSH Terms

Conditions

Myocardial InfarctionAnemia

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Howard A Cooper, M.D.

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

April 1, 2003

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations

US(3)