The Benefits of a Preoperative Anemia Management Program
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 19 - 80 |
| Updated: | 7/11/2015 |
| Start Date: | April 2013 |
| End Date: | April 2017 |
| Contact: | Thomas R Vetter, MD, MPH |
| Email: | tvetter@uab.edu |
| Phone: | 205-934-6501 |
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
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
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
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
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)
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