The Benefits of a Preoperative Anemia Management Program

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Epoetin Alfa; Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

1. 19 years to 80 years of age

2. American Society of Anesthesiologists 1-3 status

3. 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 Criteria:

1. American Society of Anesthesiologists 4 status

2. Severe anemia, defined as a hematocrit of < 30%

3. History of hypercoagulability or thrombophilia (e.g, factor V Leiden)

4. History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) within last 12 months

5. Current use of anticoagulants (e.g., heparin, warfarin, dabigatran, etc)

6. Diagnosis of chronic renal insufficiency requiring dialysis

7. Morbid obesity (BMI > 40)

8. History of allergic reaction to intravenous iron

9. History of allergic reaction to an erythropoietic stimulating agent (ESA)

10. History of sickle cell disease

11. History of hemochromatosis

12. History of liver dysfunction or congestive heart failure

13. History of substance abuse disorder

14. History of major psychiatric disorder (e.g., major depression, bipolar disorder, axis II personality disorder, schizophrenia)

15. Uncontrolled hypertension (defined as a systolic pressure ≥ 160 mmHg and/or a diastolic pressure ≥ 110 mmHg)

16. 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

17. History of pure red cell aplasia (PRCA) after treatment with an ESA

18. History of seizure disorder

19. Any active/current cancer within the last 12 months (not including non-melanoma skin cancer)

20. Pregnancy or lactation

21. Non-native English speaker (because validated Spanish language versions of two of the patient questionnaires are not available)