Clinical trial NCT01888003: The Benefits of a Preoperative Anemia Management Program
Official title: The Benefits of a Preoperative Anemia Management Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anemia, Iron-Deficiency
Keywords: anemia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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)

Primary outcomes:
measure: Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
timeFrame: During surgery (less than 1 day)
measure: Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
timeFrame: post surgery through discharge, an average of 2 days
measure: Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery
timeFrame: post hospital discharge through 90 days after surgery
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Highlands Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Thomas R Vetter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: