Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa
This study has been terminated.
(The study was stopped early due to slow enrollment)
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
Ortho Biotech Products, L.P.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210626
First received: September 13, 2005
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia |
Drug: PROCRIT Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- SF-36 PF Score [ Time Frame: Hospital Discharge to Post-Hospital Discharge Week 24 ] [ Designated as safety issue: No ]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) [ Time Frame: Hospital Discharge to Post-Hospital Discharge Week 24 ] [ Designated as safety issue: No ]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.
| Enrollment: | 192 |
| Study Start Date: | August 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: PROCRIT |
Drug: PROCRIT
40,000 IU/mL/week for max of 12 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
40,000 IU/mL/week for max of 12 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00210626 History of Changes |
| Other Study ID Numbers: | CR003235, LTTO;, Long Term Treatment Outcomes;, PR04-15-001 |
| Study First Received: | September 13, 2005 |
| Results First Received: | June 26, 2009 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care |
Additional relevant MeSH terms:
|
Anemia Critical Illness Hematologic Diseases Disease Attributes Pathologic Processes |
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013