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The Benefits of a Preoperative Anemia Management Program (PAMP)

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ClinicalTrials.gov Identifier: NCT01888003
Recruitment Status : Terminated
First Posted : June 27, 2013
Results First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas R. Vetter, MD, MPH, 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

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Drug: Iron sucrose Drug: Epoetin Alfa Other: Blood Transfusion Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Benefits of a Preoperative Anemia Management Program
Study Start Date : April 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Anemia Treatment Group (AMG)
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.
Drug: Iron sucrose
AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Other Name: (Venofer®)

Drug: Epoetin Alfa
AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females).
Other Name: PROCRIT®

Other: Blood Transfusion
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.

Conventional Treatment Group (CTG)
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.
Other: Blood Transfusion
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.

Non Anemia Group (NAG)
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Other: Blood Transfusion
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.




Primary Outcome Measures :
  1. Number of Subjects Requiring at Least One Blood Transfusion During Surgery. [ Time Frame: During surgery (less than 1 day) ]
    The number of subjects who had blood transfusions (at least 1) during surgery

  2. Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital [ Time Frame: 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

  3. Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery [ Time Frame: 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 :
  1. Health-related Quality of Life [ Time Frame: 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



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888003


Locations
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United States, Alabama
UAB Highlands Hospital
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Thomas R Vetter, MD, MPH University of Alabama at Birmingham
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Responsible Party: Thomas R. Vetter, MD, MPH, Maurice S. Albin Professor of Anesthesiology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01888003    
Other Study ID Numbers: F130117001
First Posted: June 27, 2013    Key Record Dates
Results First Posted: May 28, 2015
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Thomas R. Vetter, MD, MPH, University of Alabama at Birmingham:
anemia
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Epoetin Alfa
Ferric Oxide, Saccharated
Hematinics