The Benefits of a Preoperative Anemia Management Program

NCT01888003 | Terminated Results DMC

• 1 other identifier: F130117001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Anemia, Iron-Deficiency

Keywords

anemia

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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

Secondary Outcomes (1)

• Health-related Quality of Life

  Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery

Study Arms (3)

Anemia Treatment Group (AMG)

ACTIVE COMPARATOR

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; Drug: Epoetin Alfa; Other: Blood Transfusion

Conventional Treatment Group (CTG)

OTHER

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

Non Anemia Group (NAG)

OTHER

Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.

Other: Blood Transfusion

Interventions

Iron sucrose DRUG

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.

Also known as: (Venofer®)

Anemia Treatment Group (AMG)

Epoetin Alfa DRUG

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).

Also known as: PROCRIT®

Anemia Treatment Group (AMG)

Blood Transfusion OTHER

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.

Anemia Treatment Group (AMG); Conventional Treatment Group (CTG); Non Anemia Group (NAG)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Highlands Hospital

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

Ferric Oxide, Saccharated; Epoetin Alfa; Blood Transfusion

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Thomas Vetter
• Organization: University of Alabama at Birmingham Department of Anesthesiology and Perioperative Medicine

tvetter@uab.edu

205.934.6501

Study Officials

• Thomas R Vetter, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maurice S. Albin Professor of Anesthesiology

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: June 27, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 28, 2015
• Results First Posted: May 28, 2015

Record last verified: 2015-05

Locations

US (1)