Myocardial InfarctionPhase 4CRITNCT00126334
Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot
A Phase 4 study testing Packed Red Blood Cell Transfusion in people with Myocardial Infarction and Anemia, run by Medstar Health Research Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction, Anemia
- What is being tested?
- Packed Red Blood Cell Transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2003to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Durham VA Medical Center
Durham, North Carolina
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Washington VA Medical Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Conditions
- Myocardial Infarction, Anemia
- Being tested
- Packed Red Blood Cell Transfusion
- Keywords
- Myocardial Infarction, Anemia, Erythrocyte Transfusion
- Medical subject headings
- Myocardial Infarction, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed Red Blood Cell TransfusionProcedure or surgery
transfusion of 1 unit of PRBCs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Liberal transfusion threshold Receives: Procedure: Packed Red Blood Cell Transfusion |
| 2 | Experimental | Conservative transfusion threshold Receives: Procedure: Packed Red Blood Cell Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital death
Measured: In-hospital
Recurrent myocardial infarction (MI)
Measured: In-hospital
New or worsening heart failure
Measured: In-hospital
Secondary outcomes (12)
Critical Care Unit (CCU) length of stay
Measured: In-hospital
Length of hospitalization
Measured: In-hospital
Death or recurrent MI at hospital discharge and 30 days
Measured: 30 days
Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days
Measured: 30 days
Death at 30 days
Measured: 30 days
In-hospital recurrent ischemia
Measured: In-hospital
In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia
Measured: In-hospital
Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL)
Measured: In-hospitall
Number of transfusions received per patient
Measured: In-hospital
Proportion of patients receiving at least one transfusion
Measured: In-hospital
Mean daily hematocrit
Measured: In-hospital
Transfusion-related reactions
Measured: In-hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startApr 2003
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Investigators
- Howard A Cooper, M.D., Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126334
- Sponsor's protocol ID
- 2003-003
- Acronym
- CRIT
- Status last verified
- Jul 2011
- First submitted
- 2 Aug 2005
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41114449Carson 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.
PubMed 34932836
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot
- ClinicalTrials.gov ID
- NCT00126334
- Acronym / sponsor ID
- CRIT / 2003-003
- Conditions
- Myocardial Infarction, Anemia
- Keywords
- Myocardial Infarction, Anemia, Erythrocyte Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Apr 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Packed Red Blood Cell TransfusionLiberal transfusion threshold |
| 2 | Experimental | Procedure: Packed Red Blood Cell TransfusionConservative transfusion threshold |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Packed Red Blood Cell Transfusiontransfusion of 1 unit of PRBCs | Procedure or surgery | 1, 2 |
Primary outcome
In-hospital death
Time frame: In-hospital
Recurrent myocardial infarction (MI)
Time frame: In-hospital
New or worsening heart failure
Time frame: In-hospital
12 secondary outcomes
Critical Care Unit (CCU) length of stay
Time frame: In-hospital
Length of hospitalization
Time frame: In-hospital
Death or recurrent MI at hospital discharge and 30 days
Time frame: 30 days
Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days
Time frame: 30 days
Death at 30 days
Time frame: 30 days
In-hospital recurrent ischemia
Time frame: In-hospital
In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia
Time frame: In-hospital
Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL)
Time frame: In-hospitall
Number of transfusions received per patient
Time frame: In-hospital
Proportion of patients receiving at least one transfusion
Time frame: In-hospital
Mean daily hematocrit
Time frame: In-hospital
Transfusion-related reactions
Time frame: In-hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
- Derived from this study: PubMed 41114449Carson 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.
- Derived from this study: PubMed 34932836Carson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard A Cooper, M.D. principal investigator
Medstar Health Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Packed Red Blood Cell Transfusion in people with Myocardial Infarction and Anemia, run by Medstar Health Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital death (time frame: In-hospital). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00126334, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.