Status:

TERMINATED

Red Blood Cell Transfusion in Patients With Coronary Artery Disease (CAD)

Lead Sponsor:

Beth Israel Deaconess Medical Center

Collaborating Sponsors:

American Heart Association

Conditions:

Acute Coronary Syndrome

Anemia

Eligibility:

All Genders

18-100 years

Phase:

PHASE1

PHASE2

Brief Summary

Patients with a low blood count (anemia) with stable or unstable coronary artery disease consistently show worse clinical outcomes. It is unclear whether this association is confounded since anemic pa...

Detailed Description

Adverse clinical outcomes are reduced when critically ill patients are only transfused if their hematocrit drops below 21%: Hematocrit (HCT) is a measure of the severity of anemia. A HCT is considered...

Eligibility Criteria

Inclusion

  • ACS as defined by a patient who has cardiac chest discomfort and a troponin (cTnT) elevation of greater than 0.1 ng/mL.
  • Pt. who is s/p CABG
  • Patients with chronic coronary artery disease will be recruited as defined as past history of myocardial infarction, percutaneous coronary intervention, CABG, or history of coronary artery disease documented in the medical record.
  • Anemia as defined by HCT between 21%-30%.

Exclusion

  • Patients with stage III/IV heart failure
  • Patients who are actively bleeding requiring immediate transfusion.
  • Pregnant patients will be excluded.
  • Patients taking sildenafil (Viagra) or other drugs like it, such as vardenafil (Levitra), or tadalafil (Cialis) within 48 hours before the study.
  • Patients on iv nitroglycerine infusion.
  • Patients who present with ACS or CABG surgery and who are hemodynamically unstable or require immediate revascularization.
  • Patients who have received a blood transfusion 24 hours prior to the start of the study.
  • Patients with a HCT of \< 21% and those that have chest tube drainage greater then 30 mL/h will be excluded.

Key Trial Info

Start Date :

February 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2017

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT01504945

Start Date

February 1 2010

End Date

December 1 2017

Last Update

February 23 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215