Back to resultsThe Benefits of a Preoperative Anemia Management Program (PAMP)
Primary Purpose
Anemia, Iron-Deficiency
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iron sucrose
Epoetin Alfa
Blood Transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Iron-Deficiency focused on measuring anemia
Eligibility Criteria
Inclusion Criteria:
- 19 years to 80 years of age
- American Society of Anesthesiologists 1-3 status
- 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:
- American Society of Anesthesiologists 4 status
- Severe anemia, defined as a hematocrit of < 30%
- History of hypercoagulability or thrombophilia (e.g, factor V Leiden)
- History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) within last 12 months
- Current use of anticoagulants (e.g., heparin, warfarin, dabigatran, etc)
- Diagnosis of chronic renal insufficiency requiring dialysis
- Morbid obesity (BMI > 40)
- History of allergic reaction to intravenous iron
- History of allergic reaction to an erythropoietic stimulating agent (ESA)
- History of sickle cell disease
- History of hemochromatosis
- History of liver dysfunction or congestive heart failure
- History of substance abuse disorder
- History of major psychiatric disorder (e.g., major depression, bipolar disorder, axis II personality disorder, schizophrenia)
- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 mmHg and/or a diastolic pressure ≥ 110 mmHg)
- 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
- History of pure red cell aplasia (PRCA) after treatment with an ESA
- History of seizure disorder
- Any active/current cancer within the last 12 months (not including non-melanoma skin cancer)
- Pregnancy or lactation
- Non-native English speaker (because validated Spanish language versions of two of the patient questionnaires are not available)
Sites / Locations
- UAB Highlands Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Other
Other
Arm Label
Anemia Treatment Group (AMG)
Conventional Treatment Group (CTG)
Non Anemia Group (NAG)
Arm Description
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.
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.
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Outcomes
Primary Outcome Measures
Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
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
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
number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery
Secondary Outcome Measures
Health-related Quality of Life
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
Full Information
NCT ID
NCT01888003
First Posted
March 20, 2013
Last Updated
May 26, 2015
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT01888003
Brief Title
The Benefits of a Preoperative Anemia Management Program
Acronym
PAMP
Official Title
The Benefits of a Preoperative Anemia Management Program
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-Deficiency
Keywords
anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anemia Treatment Group (AMG)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Treatment Group (CTG)
Arm Type
Other
Arm Description
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.
Arm Title
Non Anemia Group (NAG)
Arm Type
Other
Arm Description
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Intervention Type
Drug
Intervention Name(s)
Iron sucrose
Other Intervention Name(s)
(Venofer®)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Other Intervention Name(s)
PROCRIT®
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Blood Transfusion
Intervention Description
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 Measure Information:
Title
Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
Description
The number of subjects who had blood transfusions (at least 1) during surgery
Time Frame
During surgery (less than 1 day)
Title
Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
Description
Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital
Time Frame
post surgery through discharge, an average of 2 days
Title
Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery
Description
number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery
Time Frame
post hospital discharge through 90 days after surgery
Secondary Outcome Measure Information:
Title
Health-related Quality of Life
Description
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
Time Frame
Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19 years to 80 years of age
American Society of Anesthesiologists 1-3 status
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:
American Society of Anesthesiologists 4 status
Severe anemia, defined as a hematocrit of < 30%
History of hypercoagulability or thrombophilia (e.g, factor V Leiden)
History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) within last 12 months
Current use of anticoagulants (e.g., heparin, warfarin, dabigatran, etc)
Diagnosis of chronic renal insufficiency requiring dialysis
Morbid obesity (BMI > 40)
History of allergic reaction to intravenous iron
History of allergic reaction to an erythropoietic stimulating agent (ESA)
History of sickle cell disease
History of hemochromatosis
History of liver dysfunction or congestive heart failure
History of substance abuse disorder
History of major psychiatric disorder (e.g., major depression, bipolar disorder, axis II personality disorder, schizophrenia)
Uncontrolled hypertension (defined as a systolic pressure ≥ 160 mmHg and/or a diastolic pressure ≥ 110 mmHg)
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
History of pure red cell aplasia (PRCA) after treatment with an ESA
History of seizure disorder
Any active/current cancer within the last 12 months (not including non-melanoma skin cancer)
Pregnancy or lactation
Non-native English speaker (because validated Spanish language versions of two of the patient questionnaires are not available)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Vetter, MD, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Highlands Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Benefits of a Preoperative Anemia Management Program
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