AnemiaPhase 2NCT00210626
Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa
A Phase 2 study testing PROCRIT in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anemia
- What is being tested?
- PROCRIT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 21 sitesUnited States
- Study dates
- Aug 2005to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Allentown, Pennsylvania
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Cincinnati, Ohio
Study site
Dayton, Ohio
Study site
Denver, Colorado
Study site
El Paso, Texas
Study site
Gainesville, Florida
Study site
Hollywood, Florida
Study site
Indianapolis, Indiana
Study site
Las Vegas, Nevada
Study site
Maywood, Illinois
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Morgantown, West Virginia
Study site
Norfolk, Virginia
Study site
Orange, California
Study site
Philadelphia, Pennsylvania
Study site
Santa Barbara, California
Study site
Springfield, Illinois
Study site
St Louis, Missouri
About this study
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
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- PROCRIT, Placebo
- Keywords
- Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care
- Medical subject headings
- Anemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCRITDrug
40,000 IU/mL/week for max of 12 weeks
PlaceboDrug
40,000 IU/mL/week for max of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| PROCRIT | Active comparator | Not described Receives: Drug: PROCRIT |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hospital Discharge to Post-Hospital Discharge Week 24
Secondary outcomes (1)
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.
Measured: Hospital Discharge to Post-Hospital Discharge Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Responsible party
- Sponsor
- Investigators
- Tracy McGowan, Study director, Janssen Services, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210626
- Sponsor's protocol ID
- CR003235
- Other IDs
- LTTO;, Long Term Treatment Outcomes;, PR04-15-001
- Status last verified
- Apr 2014
- First submitted
- 13 Sep 2005
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00210626
- Acronym / sponsor ID
- CR003235
- Conditions
- Anemia
- Keywords
- Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- Aug 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 22 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROCRIT | Active comparator | Drug: PROCRIT |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROCRIT40,000 IU/mL/week for max of 12 weeks | Drug | PROCRIT |
| Placebo40,000 IU/mL/week for max of 12 weeks | Drug | Placebo |
Primary outcome
SF-36 PF Score
Time frame: Hospital Discharge to Post-Hospital Discharge Week 24
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.
1 secondary outcome
Return to Usual Activity (RTUA)
Time frame: Hospital Discharge to Post-Hospital Discharge Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy McGowan study director
Janssen Services, LLC
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PROCRIT in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 PF Score (time frame: Hospital Discharge to Post-Hospital Discharge Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.