PROCRIT and Short-Term Outcomes in Orthopedic Surgery | NCT00236405

Studies
PROCRIT and Short-Term Outcomes in Orthopedic Surgery

NCT00236405

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Status

Terminated

Last Update Posted

Jun 10, 2011Estimated

Enrollment

6Actual

Phase

Phase 2

Conditions

Anemia
Surgery, Arthroscopy

Interventions

epoetin alfa

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated due to poor enrollment.

Expanded Access Info

Not provided

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Oct 2005Actual

First Submitted Date

Oct 7, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2011

Last Update Posted Date

Jun 10, 2011Estimated

Name	Class
Ortho Biotech Products, L.P.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the effect of perioperative administration of PROCRIT to that of autologous blood donation on post-operative rehabilitation outcomes in patients undergoing unilateral knee surgery.

Detailed Description

The primary objective of this study is to compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on post-operative rehabilitation outcomes in subjects undergoing primary unilateral knee arthroplasty.

Secondary objectives are : 1) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on hemoglobin, change in hemoglobin, number of units transfused and transfusion rate during the study period; and 2) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on inpatient rehabilitation length of stay.

The study will test the hypothesis that perioperative administration of PROCRIT will improve post-operative rehabilitation outcomes, compared with preoperative autologous donation. 40,000U PROCRIT or Placebo SC in relation to surgery date: Days -21, -14, -7, 0 (day of surgery), 7, and 14.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Name	Type	Description	Arm Group Labels	Other Names
epoetin alfa	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint is the change in composite FIM scores (from entry into the inpatient rehabilitation facility to discharge from inpatient rehabilitation) divided by the LOS, denoted as DFIM/LOS, or "rate of functional recovery".

Secondary Outcomes

Measure	Description	Time Frame
LOS in the inpatient rehabilitation facility; Total FIM score; FIM Physical Sub-score LASA score; FACIT-An score. Safety evaluations include the incidence of adverse events throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for primary unilateral knee arthroplasty with an expected discharge into an inpatient rehabilitation facility
Hemoglobin >11 to <13 g/dL at screening and preoperative day -21
Age 18 years or older
Female subjects must be post-menopausal for at least one year or surgically sterile (hysterectomy or tubal ligation). Women of childbearing age must have negative pregnancy test(s) (serum HCG RIA at screening and urine at preoperative day -21, if applicable
Preoperative lead time of at least 21 days

Exclusion Criteria:

Medical conditions including: Known iron deficiency (defined as serum ferritin <50 mg/l)
chronic renal failure, significant hematological disease, uncontrolled hypertension, new onset seizures/uncontrolled seizures
Expected to need another lower extremity major joint replacement within six months
Undergoing cancer chemotherapy
History of thrombotic vascular events including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

Locations

Not provided

References Module

Citations

Not provided

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates