- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00401869
The Effect of PROCRIT (Epoetin Alfa) on Postoperative Vigor and Handgrip Strength (VIGOR Study)
April 5, 2010 updated by: Ortho Biotech, Inc.
The Effect of PROCRIT on Hemoglobin and Hematocrit and the Relationship to Postoperative Function, Vigor and Strength in Patients Undergoing Primary Total Joint Arthroplasty: A Randomized, Parallel Group, Open-Label Trial
The purpose of this study was to compare the effect of epoetin alfa to preoperative autologous blood donation (PAD) on postoperative vigor (a measure of functional ability and well-being) and handgrip strength in patients undergoing hip or knee surgery.
Study Overview
Detailed Description
Total joint arthroplasty (including hip and knee surgery) often leads to significant blood loss and may result in the need for blood transfusion.
To prepare for this possibility, patients frequently donate their own blood in advance of their surgery so that it is available if transfusion is required during or after the procedure.
This process of self-donation is known as preoperative autologous blood donation (PAD).
PAD is associated with certain limitations including for example, worsening pre-operative anemia (potentially leading to the need for transfusion) and questionable cost-effectiveness.
PROCRIT (Epoetin alfa) is a hormone that stimulates red blood cells production.
Administration of PROCRIT (Epoetin alfa) is also used presurgically in anemic patients undergoing elective noncardiac, nonvascular surgery to increase hemoglobin levels (red blood cells) and reduce the need for transfusion during or after surgery.
PROCRIT (Epoetin alfa) has been shown specifically to increase hemoglobin levels and reduce the need for blood transfusion in patients who undergo hip or knee surgery.
However, no studies have been done to evaluate the ability of epoetin alfa to enhance energy and quality-of-life in patients having hip or knee surgery.
This study was undertaken to compare two methods of blood management (Epoetin alfa treatment versus PAD) in terms of vigor score (functional activity and well-being).
Other outcomes of study include handgrip strength, post-operative hemoglobin levels, and number of patients requiring transfusion.
This was a randomized (patients were assigned to each treatment group by chance), open-label (both patient and physician know what treatment group the patient is assigned to) trial.
Patients randomly assigned to treatment with PROCRIT (Epoetin alfa) received a subcutaneous injection of 600 IU/kg once weekly for 3 weeks preoperatively and then within 24 hours postoperatively.
Patients in the PAD group were to donate 1 unit of blood before total knee arthroplasty, and 2 units of blood before total hip arthroplasty, as tolerated, beginning up to 28 days before surgery.
Patients were not permitted to receive both study treatments.
Daily oral iron supplementation was given in both treatment groups.
It was recommended that blood transfusions should not be given if the patient had hemoglobin greater than or equal to 8 g/dL unless clinical symptoms or patient history warranted intervention.
Investigators were instructed to use identical criteria for autologous and allogeneic blood transfusions.
Baseline measurements including hemoglobin, hematocrit, red blood cell count, white blood cell count, reticulocytes, vigor, and handgrip strength were collected 28 to 21 days before surgery.
Hemoglobin, vigor, and handgrip strength were repeated within 24 hours before surgery and again on Day 2, Day 4 or 5 (or discharge), and once between days 14 to 21 after surgery.
Safety was assessed throughout the study by monitoring the occurrence and severity of adverse events including infection and thromboembolism.
Patients assigned to the epoetin alfa group received 600 IU/kg PROCRIT (Epoetin alfa) administered subcutaneously (under the skin) once weekly for 3 weeks preoperatively and once 24 hours after surgery.
Study Type
Interventional
Enrollment (Actual)
289
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Scheduled for elective unilateral (one joint), primary total joint arthroplasty of hip or knee
- pretreatment hemoglobin level of 11 to 14 g/dL
- enrollment 21-60 days in advance of surgery
Exclusion Criteria:
- No uncontrolled hypertension
- No seizure disorder
- No history of deep vein thrombosis
- No significant gastrointestinal bleeding in previous 6 months
- No clinically significant hematologic, cardiovascular, neurological, pulmonary, endocrine, gastrointestinal, or genitourinary disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The change in VIGOR score (as assessed by questionnaire) from baseline to 1) within 24 hours of surgery; 2) post-op Day 2; 3) Day 4 or 5 or hospital discharge; and 4) between post-op days 14 and 21.
|
Secondary Outcome Measures
Outcome Measure |
---|
Handgrip strength (JAMAR Hand Dynamometer using the stronger hand and in a standardized position and method repeated 3 times - the maximum force exerted was recorded), hemoglobin, and incidence of transfusion as described for primary outcome intervals.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ortho Biotech, Inc. Clinical Trial, Ortho Biotech, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1999
Study Completion (Actual)
December 1, 2001
Study Registration Dates
First Submitted
November 17, 2006
First Submitted That Met QC Criteria
November 20, 2006
First Posted (Estimate)
November 22, 2006
Study Record Updates
Last Update Posted (Estimate)
April 6, 2010
Last Update Submitted That Met QC Criteria
April 5, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR012205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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