The Benefits of a Preoperative Anemia Management Program

Not Applicable

Terminated

• Conditions: Anemia, Iron-Deficiency
• Interventions: Drug: Iron sucrose; Other: Blood Transfusion; Drug: Epoetin Alfa

• Registration Number: NCT01888003
• Lead Sponsor: University of Alabama at Birmingham

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 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

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 levels, optimize blood clotting, and minimize blood loss, in an effort to improve patient outcome. PBM focuses on the treatment of the individual patient and comprises transfusion therapy and drug therapy. PBM is based on three points: (1) optimization of the (preoperative) red blood cell volume, (2) reduction of diagnostic, therapeutic, or intraoperative blood loss, and (3) increasing individual tolerance towards anemia and accurate blood transfusion triggers. PBM primarily identifies patients at risk for transfusion and provides a management plan aimed at reducing or eliminating anemia and the need for blood transfusion donated from someone other than the patient (allogeneic transfusion), thus reducing the risks, blood bank inventory pressures, and the escalating costs associated with transfusion. The implementation of a formal UAB Preoperative Anemia Management Program (PAMP) may help achieve consistent PBM.

Efforts will be made to coordinate patients' scheduled surgery date and their initial evaluation in the UAB Highlands Hospital Preoperative Assessment, Consultation, and Treatment (HPACT) Clinic, so that their first PACT Clinic visit occurs approximately 14 days prior to the planned total hip replacement or total knee replacement

Study Timeline

• Study First Submitted: 2013-03-20
• Study Start: 2013-04
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-27
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2015-03-20
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-26
• Last Update Submitted: 2015-05-26
• Results First Posted: 2015-05-28
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anemia Treatment Group (AMG)	Iron sucrose	Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Non Anemia Group (NAG)	Blood Transfusion	Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Anemia Treatment Group (AMG)	Blood Transfusion	Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Conventional Treatment Group (CTG)	Blood Transfusion	Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.
Anemia Treatment Group (AMG)	Epoetin Alfa	Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Requiring at Least One Blood Transfusion During Surgery.	During surgery (less than 1 day)	The number of subjects who had blood transfusions (at least 1) during surgery
Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital	post surgery through discharge, an average of 2 days	Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital
Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery	post hospital discharge through 90 days after surgery	number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life	Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery	Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale

Trial Locations

Locations (1)

UAB Highlands Hospital; 🇺🇸 Birmingham, Alabama, United States