Blood TransfusionPhase 2NCT00270036
A Study to Determine the Safety of Epoetin Alfa and Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients After Major Orthopedic Surgery.
A Phase 2 study testing epoetin alfa in people with Blood Transfusion and Orthopedic Procedures, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Transfusion, Orthopedic Procedures, Anemia
- What is being tested?
- epoetin alfa
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Apr 1991to Oct 1991
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for major orthopedic surgery who are expected to require transfusion of at least 2 units of red blood cells
- who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery
- having no significantly abnormal blood or urine test results
- having a hematocrit <= 45%
Who cannot join
- Patients with any blood disease, significant heart and blood vessel disease or signs and symptoms of other significant disease and/or dysfunction
- having signs and symptoms of significant and ongoing blood loss
- having a seizure disorder, uncontrolled high blood pressure, or infections or cancers that may make it difficult to respond to the study drug
- received medication known to suppress the formation of red blood cells within 1 month before the start of the study
- received a blood transfusion within 1 month before the start of the study
About this study
Official title: A Double-Blind, Placebo-Controlled Study to Determine the Safety of r-HuEPO and Whether r-HuEPO Can Reduce Post-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery
The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Read the detailed description
Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the need for blood transfusions. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin, that stimulates red blood cell production. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study compares the effectiveness of epoetin alfa in reducing the need for blood transfusions in patients who are expected to require at least 2 units of blood following major orthopedic surgery. Eligible patients will be randomly assigned to receive either epoetin alfa (100 or 300 U/kg, depending upon their body weight) or a matching placebo, by injection beneath the skin starting 10 days before scheduled surgery, on the day of surgery (after surgery), and for 4 days after surgery. Additionally, all patients will start taking an oral iron supplement at least 10 days before their scheduled surgery. Effectiveness will be determined by the number of transfusions required following surgery, and on changes in hematocrit (iron-containing pigment in red blood cells), hemoglobin (oxygen-carrying component of red blood cells), and reticulocyte (immature red blood cells) levels from the start of the study to the end of the study. Safety evaluations will include the incidence and severity of adverse events, and changes in clinical laboratory tests, vital signs, and physical examination findings throughout the study. The study hypothesis is that patients treated with epoetin alfa will require fewer blood transfusions after surgery than patients treated with placebo. Epoetin alfa (300 U/kg or 100 U/kg), or matching placebo, by injection beneath the skin beginning 10 days before scheduled surgery and ending 4 days after surgery.
- Conditions
- Blood Transfusion, Orthopedic Procedures, Anemia
- Being tested
- epoetin alfa
- Keywords
- Blood transfusion, epoetin alfa, epogen, erythropoietin, orthopedic procedures, orthopedic surgery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion requirements following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study
Secondary outcomes (1)
Adverse events; Changes in clinical laboratory test results, vital signs, and physical examination findings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startApr 1991
- Study completionOct 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood TransfusionStudies 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
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270036
- Sponsor's protocol ID
- CR005902
- Status last verified
- Nov 2010
- First submitted
- 22 Dec 2005
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study to Determine the Safety of r-HuEPO and Whether r-HuEPO Can Reduce Post-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT00270036
- Acronym / sponsor ID
- CR005902
- Conditions
- Blood Transfusion, Orthopedic Procedures, Anemia
- Keywords
- Blood transfusion, epoetin alfa, epogen, erythropoietin, orthopedic procedures, orthopedic surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 1991
- Study completion
- Oct 1991 (actual)
- First posted
- 26 Dec 2005 (estimated)
- Results
- Not posted in the source record
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 study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Detailed description
Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the need for blood transfusions. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin, that stimulates red blood cell production. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study compares the effectiveness of epoetin alfa in reducing the need for blood transfusions in patients who are expected to require at least 2 units of blood following major orthopedic surgery. Eligible patients will be randomly assigned to receive either epoetin alfa (100 or 300 U/kg, depending upon their body weight) or a matching placebo, by injection beneath the skin starting 10 days before scheduled surgery, on the day of surgery (after surgery), and for 4 days after surgery. Additionally, all patients will start taking an oral iron supplement at least 10 days before their scheduled surgery. Effectiveness will be determined by the number of transfusions required following surgery, and on changes in hematocrit (iron-containing pigment in red blood cells), hemoglobin (oxygen-carrying component of red blood cells), and reticulocyte (immature red blood cells) levels from the start of the study to the end of the study. Safety evaluations will include the incidence and severity of adverse events, and changes in clinical laboratory tests, vital signs, and physical examination findings throughout the study. The study hypothesis is that patients treated with epoetin alfa will require fewer blood transfusions after surgery than patients treated with placebo. Epoetin alfa (300 U/kg or 100 U/kg), or matching placebo, by injection beneath the skin beginning 10 days before scheduled surgery and ending 4 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for major orthopedic surgery who are expected to require transfusion of at least 2 units of red blood cells
- who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery
- having no significantly abnormal blood or urine test results
- having a hematocrit <= 45%
Key exclusion criteria (5 listed)
- Patients with any blood disease, significant heart and blood vessel disease or signs and symptoms of other significant disease and/or dysfunction
- having signs and symptoms of significant and ongoing blood loss
- having a seizure disorder, uncontrolled high blood pressure, or infections or cancers that may make it difficult to respond to the study drug
- received medication known to suppress the formation of red blood cells within 1 month before the start of the study
- received a blood transfusion within 1 month before the start of the study
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 |
|---|---|---|
| epoetin alfa | Drug | – |
Primary outcome
Transfusion requirements following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study
1 secondary outcome
Adverse events; Changes in clinical laboratory test results, vital signs, and physical examination findings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- A study to determine the safety of epoetin and whether epoetin alfa can reduce the need for blood transfusion in patients after major orthopedic surgeryLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epoetin alfa in people with Blood Transfusion and Orthopedic Procedures, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transfusion requirements following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study. 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 18 May 2011.