Status:
TERMINATED
Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
AMAG Pharmaceuticals, Inc.
Conditions:
Anemia
Cardiovascular Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major health problem for patients having heart surgery. Hemoglobin is the part of our blood that carries oxygen from...
Detailed Description
Anemia and transfusion are independent predictors of morbidity and mortality in the cardiac surgical patient population. Even so, active preoperative anemia management is not currently the standard of...
Eligibility Criteria
Inclusion
- between the age of 18 and 80 years old
- diagnosed with preoperative anemia, defined as hemoglobin \<13.0 grams per deciliter (g/dL)
- scheduled for elective cardiac surgery (CABG, valve, or CABG/valve), including both first time and repeat procedures
- documented negative pregnancy test within 7 days prior to the procedure for females of child-bearing potential
- a written informed consent prior to any procedure, using a form that is approved by the UT Southwestern Institutional Review Board
- agreement to be compliant
Exclusion
- uncontrolled hypertension (defined as systolic pressure greater than 180 millimeters of mercury (mmHg), diastolic pressure greater than 100mmHg, not adequately controlled by anti-hypertensive therapy at the time of procedure)
- current renal failure on dialysis or serum creatinine \>3.0 milligrams per deciliter (mg/dL)
- unstable angina (defined by chest pain and EKG changes indicating ischemia at rest)
- thromboembolism within the past year
- current active primary or metastatic malignancy or history of myeloid malignancy
- seizures within the past year
- history of stroke within the last 6 months
- patients who have platelet count lower than 50,000 per cubic millimeter (mm3) or coagulation abnormality
- sepsis or bacteremia defined by positive blood culture
- patients who have known hypersensitivity to EPO or any of its components
- patients who have known hypersensitivity to Feraheme or any of its components
- patients who refuse blood transfusion, (i.e. Jehovah's Witnesses)
- pregnant or breast feeding
- patients who are unable to provide informed consent or who has inability to understand or corporate with study procedure
Key Trial Info
Start Date :
April 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02189889
Start Date
April 9 2013
End Date
July 26 2019
Last Update
October 23 2020
Active Locations (2)
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1
Clements University Hospital
Dallas, Texas, United States, 75390-8894
2
Clements University Hospital
Dallas, Texas, United States, 75390