TraumaEPREXNCT03867071
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
A study testing recombinant erythropoietin injection in people with Trauma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma
- What is being tested?
- recombinant erythropoietin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2005to Jul 2012
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 to 65 years old
- Patient with an ASA 1 or 2 (ASA 1 corresponding to a patient in perfect health and ASA 2 to a patient with moderate involvement and well controlled organ function)
- patient presenting at least one of the following fractures: Basin and / or femur with surgical indication, associated or not with other fractures.
- patient with hemoglobin between 9 and 13 g / dl at the time of admission on trauma department
Who cannot join
- patient with contraindication to synthetic erythropoietin
- Patient with intravenous iron contraindication
- pregnant patient or with a risk of pregnancy
- patient who has not given his consent or does not understand the protocol
- Patient with hemodynamic instability
- patient participating in another research protocol for less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients
Read the detailed description
Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?
- Conditions
- Trauma
- Being tested
- recombinant erythropoietin injection, placebo injection
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant erythropoietin injectionOther
Intravenous injection of 300 international units (IU) per kg (kg) of recombinant erythropoietin with a maximum of 20.000 IU, daily for a maximum of 10 days (D0 to D9).
placebo injectionOther
Intravenous injection 0,9% saline solution.
| Study group | Role | What they receive |
|---|---|---|
| erythropoietin (EPO) group | Experimental | Not described Receives: Other: recombinant erythropoietin injection |
| Placebo (PLA) group | Placebo comparator | Not described Receives: Other: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of administered red blood cells
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study startOct 2005
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867071
- Sponsor's protocol ID
- PHRCI/2004/AC-01
- Acronym
- EPREX
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
- ClinicalTrials.gov ID
- NCT03867071
- Acronym / sponsor ID
- EPREX / PHRCI/2004/AC-01
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2005 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Mar 2019 (actual)
- 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 objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients
Detailed description
Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erythropoietin (EPO) group | Experimental | Other: recombinant erythropoietin injection |
| Placebo (PLA) group | Placebo comparator | Other: placebo injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18 to 65 years old
- Patient with an ASA 1 or 2 (ASA 1 corresponding to a patient in perfect health and ASA 2 to a patient with moderate involvement and well controlled organ function)
- patient presenting at least one of the following fractures: Basin and / or femur with surgical indication, associated or not with other fractures.
- patient with hemoglobin between 9 and 13 g / dl at the time of admission on trauma department
Key exclusion criteria (6 listed)
- patient with contraindication to synthetic erythropoietin
- Patient with intravenous iron contraindication
- pregnant patient or with a risk of pregnancy
- patient who has not given his consent or does not understand the protocol
- Patient with hemodynamic instability
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 |
|---|---|---|
| recombinant erythropoietin injectionIntravenous injection of 300 international units (IU) per kg (kg) of recombinant erythropoietin with a maximum of 20.000 IU, daily for a maximum of 10 days (D0 to D9). | Other | erythropoietin (EPO) group |
| placebo injectionIntravenous injection 0,9% saline solution. | Other | Placebo (PLA) group |
Primary outcome
number of administered red blood cells
Time frame: Day 30
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 7 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant erythropoietin injection in people with Trauma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 6 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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
number of administered red blood cells (time frame: Day 30). 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 7 Mar 2019.