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Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa

Primary Purpose

Anemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PROCRIT
Placebo
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ICU admission secondary to a blunt multi-system traumatic injury A leg or pelvic fracture must be one of the injuries sustained Male or female Age between 18 and 55 years Hemoglobin <=12g/dL at study entry An expected ICU stay >=2 days Glascow Coma Scale (GCS) score must be >= 13 at hospital admission or within 24 hours of admission Documented ability to function independently prior to this hospitalization as determined by a subject or proxy interview using the Karnofsky Performance scale and having a score >=80 Subjects (or appropriate legal representative) must sign the informed consent form after the nature of the study has been fully explained Female subjects that can become pregnant must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during study Subjects must be literate in their native language in order to complete written self-assessments during the post-hospital discharge phase Exclusion Criteria: Acute burns Traumatic Brain Injury (TBI) with admission GCS <= 12 and/or spinal cord injury Cause of injury secondary to a fall from a standing position Trauma victims transferred into the participating institution > 8 hours post injury Subjects not expected to survive 12 months given their injuries and/or pre-existing, uncorrectable medical condition Chronic renal failure on dialysis Significant hematological disease All subjects expected to undergo chemotherapy during the course of treatment A current diagnosis of uncontrolled hypertension New onset seizures (within three months) or seizures not controlled by medication prior to admission Gustillo III fracture, open pelvic fracture, traumatic amputation Prior history or diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or genetic coagulation abnormality Pregnancy or lactation Refusal to accept blood transfusion Received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment Treatment with any recombinant human erythropoietin within 30 days prior to enrollment - Known hypersensitivity to human albumin or mammalian cell-derived products or epoetin alfa Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PROCRIT

Placebo

Arm Description

Outcomes

Primary Outcome Measures

SF-36 PF Score
Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.

Secondary Outcome Measures

Return to Usual Activity (RTUA)
Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.

Full Information

First Posted
September 13, 2005
Last Updated
April 2, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Ortho Biotech Products, L.P.
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1. Study Identification

Unique Protocol Identification Number
NCT00210626
Brief Title
Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Recombinant Human Erythropoietin (Epoetin Alfa (PROCRIT®)) on Functional Outcomes in Anemic, Critically Ill, Trauma Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Ortho Biotech Products, L.P.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to evaluate the physical function outcomes in anemic, critically ill, trauma subjects treated with epoetin alfa (PROCRIT®) compared to placebo.
Detailed Description
The overall study design is based on the assumption that the maximum increase in red blood cells and their effect often does not occur while a subject is in the ICU and acutely ill. The study hypothesis is that a higher hemoglobin (red blood cells) carries more oxygen and delivers oxygen to the tissues. This should increase the ability of the injured subject to tolerate the physical exertion involved in the recuperative process and thus recover earlier than someone with a lower hemoglobin. One milliliter of a colorless liquid is injected under the subjects skin weekly during their hospital stay and weekly for up to an additional 12 weeks after hospital discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROCRIT
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PROCRIT
Intervention Description
40,000 IU/mL/week for max of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
40,000 IU/mL/week for max of 12 weeks
Primary Outcome Measure Information:
Title
SF-36 PF Score
Description
Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.
Time Frame
Hospital Discharge to Post-Hospital Discharge Week 24
Secondary Outcome Measure Information:
Title
Return to Usual Activity (RTUA)
Description
Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.
Time Frame
Hospital Discharge to Post-Hospital Discharge Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICU admission secondary to a blunt multi-system traumatic injury A leg or pelvic fracture must be one of the injuries sustained Male or female Age between 18 and 55 years Hemoglobin <=12g/dL at study entry An expected ICU stay >=2 days Glascow Coma Scale (GCS) score must be >= 13 at hospital admission or within 24 hours of admission Documented ability to function independently prior to this hospitalization as determined by a subject or proxy interview using the Karnofsky Performance scale and having a score >=80 Subjects (or appropriate legal representative) must sign the informed consent form after the nature of the study has been fully explained Female subjects that can become pregnant must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during study Subjects must be literate in their native language in order to complete written self-assessments during the post-hospital discharge phase Exclusion Criteria: Acute burns Traumatic Brain Injury (TBI) with admission GCS <= 12 and/or spinal cord injury Cause of injury secondary to a fall from a standing position Trauma victims transferred into the participating institution > 8 hours post injury Subjects not expected to survive 12 months given their injuries and/or pre-existing, uncorrectable medical condition Chronic renal failure on dialysis Significant hematological disease All subjects expected to undergo chemotherapy during the course of treatment A current diagnosis of uncontrolled hypertension New onset seizures (within three months) or seizures not controlled by medication prior to admission Gustillo III fracture, open pelvic fracture, traumatic amputation Prior history or diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or genetic coagulation abnormality Pregnancy or lactation Refusal to accept blood transfusion Received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment Treatment with any recombinant human erythropoietin within 30 days prior to enrollment - Known hypersensitivity to human albumin or mammalian cell-derived products or epoetin alfa Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy McGowan
Organizational Affiliation
Janssen Services, LLC
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Orange
State/Province
California
Country
United States
City
Santa Barbara
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Hollywood
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

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Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa

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