Status:
TERMINATED
The Benefits of a Preoperative Anemia Management Program
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Anemia, Iron-Deficiency
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
The goal of this study is to gain further insight into the comparative effectiveness of treating patients, who are found to be anemic before their elective surgery, with a series of weekly subcutaneou...
Detailed Description
Patient blood management (PBM) involves the timely and conscientious use of the current best evidence in making medical and surgical decisions about the care of patients to maintain red blood cell lev...
Eligibility Criteria
Inclusion
- 19 years to 80 years of age
- American Society of Anesthesiologists 1-3 status
- Undergoing total hip arthroplasty for osteoarthritis, (either a primary or replacement procedure, but not a revision procedure) OR avascular necrosis (AVN); OR undergoing total knee arthroplasty (replacement) for osteoarthritis
Exclusion
- American Society of Anesthesiologists 4 status
- Severe anemia, defined as a hematocrit of \< 30%
- History of hypercoagulability or thrombophilia (e.g, factor V Leiden)
- History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) within last 12 months
- Current use of anticoagulants (e.g., heparin, warfarin, dabigatran, etc)
- Diagnosis of chronic renal insufficiency requiring dialysis
- Morbid obesity (BMI \> 40)
- History of allergic reaction to intravenous iron
- History of allergic reaction to an erythropoietic stimulating agent (ESA)
- History of sickle cell disease
- History of hemochromatosis
- History of liver dysfunction or congestive heart failure
- History of substance abuse disorder
- History of major psychiatric disorder (e.g., major depression, bipolar disorder, axis II personality disorder, schizophrenia)
- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 mmHg and/or a diastolic pressure ≥ 110 mmHg)
- History of uncontrolled cardiac arrhythmias, cerebrovascular accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or other arterial thrombosis. ACS includes unstable angina, Q wave myocardial infarction (QwMI), and non-Q wave myocardial infarction (NQMI) within 6 months
- History of pure red cell aplasia (PRCA) after treatment with an ESA
- History of seizure disorder
- Any active/current cancer within the last 12 months (not including non-melanoma skin cancer)
- Pregnancy or lactation
- Non-native English speaker (because validated Spanish language versions of two of the patient questionnaires are not available)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01888003
Start Date
April 1 2013
End Date
January 1 2015
Last Update
May 28 2015
Active Locations (1)
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1
UAB Highlands Hospital
Birmingham, Alabama, United States, 35294