The Benefits of a Preoperative Anemia Management Program

Anemia, Iron-Deficiency Clinical Trial

— PAMP  

Official title:

The Benefits of a Preoperative Anemia Management Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01888003
• Other study ID #: F130117001
• Status: Terminated
• Phase: N/A
• First received: March 20, 2013
• Last updated: May 26, 2015
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

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.
• 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:
• 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.

Locations

Country	Name	City	State
United States	UAB Highlands Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Requiring at Least One Blood Transfusion During Surgery.	The number of subjects who had blood transfusions (at least 1) during surgery	During surgery (less than 1 day)	Yes
Primary	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	post surgery through discharge, an average of 2 days	Yes
Primary	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	post hospital discharge through 90 days after surgery	Yes
Secondary	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	Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery	No