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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

Tracking Information
First Submitted Date  ICMJE March 20, 2013
First Posted Date  ICMJE June 27, 2013
Results First Submitted Date  ICMJE March 20, 2015
Results First Posted Date  ICMJE May 28, 2015
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
Need for blood transfusion during and after surgery. [ Time Frame: Intraoperatively, postoperatively during initial surgical hospitalization, and during the first 90 days after hospital discharge ]
The need for blood transfusions during and after surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
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; and Multidimensional Assessment of Fatigue (MAF) Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Benefits of a Preoperative Anemia Management Program
Official Title  ICMJE The Benefits of a Preoperative Anemia Management Program
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia, Iron-Deficiency
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Iron sucrose
    • Drug: Epoetin Alfa
    • Other: Blood Transfusion
  • 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.
    Intervention: Other: Blood Transfusion
  • Non Anemia Group (NAG)
    Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
    Intervention: Other: Blood Transfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
51
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2013)
500
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888003
Other Study ID Numbers  ICMJE F130117001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas R. Vetter, MD, MPH, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas R Vetter, MD, MPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP