The Benefits of a Preoperative Anemia Management Program

Stopped early · Not applicable

Conditions studied: Anemia, Iron-Deficiency

In brief

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 subcutaneous doses of a drug given before surgery, which stimulates the natural production of red blood cells (a so-called erythropoietic stimulating agent \[ESA\]) along with intravenous iron, in reducing the need for blood transfusions (donated by someone other than the patient) during and after adult total hip arthroplasty (hip replacement surgery). The effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery will also be examined. A cost-effectiveness analysis will be performed to compare the cost of these commercially available, FDA-approved medications versus the cost of transfused blood

Key facts

Study ID

NCT01888003

Run by

University of Alabama at Birmingham

People needed

51

Starts

2013-04-01

Expected to finish

2015-01-01

Last updated by the study team

2015-05-28

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UAB Highlands Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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