Multiple TraumaPhase 2EPREXNCT00622934
Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients
A Phase 2 study testing erythropoietin in people with Multiple Trauma, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether Erythropoietin decrease stress responses and inflammation in trauma patient. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Multiple Trauma
- What is being tested?
- erythropoietin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jul 2007to May 2008
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All multiple trauma patients>16 years with informed consent
Who cannot join
- Hypertension
- Allergy
- Erythroid leukemia
- Pregnancy and breast feeding
- Pre operative patient
- Severe cardiovascular and cerebrovascular diseases
- Thromboembolic disorders
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Sina Hospital
Tehran
MOJTAHEDZADE, 098216701041-9
MOHAMMADY, 0989126053454
About this study
Official title: Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit
The purpose of this study is to determine whether Erythropoietin decrease stress responses and inflammation in trauma patient.
Read the detailed description
Transfusion of blood products has many disadvantages. Erythropoietin is used to increase red blood cells production and decrease such disadvantages.In some studies anti inflammatory effects is shown for Erythropoietin.
One of the most problems in the intensive care unit is stress response. we are going to evaluate effects of erythropoietin on oxidative stress and inflammation in trauma patient in intensive care unit.
- Conditions
- Multiple Trauma
- Being tested
- erythropoietin, placebo
- Keywords
- multiple trauma
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Also called EPREX
300mg/kg erythropoietin 3 times on the first week of admission
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: erythropoietin |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
apachi 2 saps 30 days mortality
Measured: untill discharge
Secondary outcomes (1)
30 days mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionMay 2008 (estimated)
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- MOJTABA MOJTAHEDZADE, Study chair, TUMSMOSTAFA MOHAMMADY, Principal investigator, TUMSMOJTABA MOJTAHED, Study director, TUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622934
- Sponsor's protocol ID
- 425/195 13/4/86
- Acronym
- EPREX
- Status last verified
- Nov 2010
- First submitted
- 13 Feb 2008
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00622934
- Acronym / sponsor ID
- EPREX / 425/195 13/4/86
- Conditions
- Multiple Trauma
- Keywords
- multiple trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2008 (estimated)
- First posted
- 25 Feb 2008 (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 whether Erythropoietin decrease stress responses and inflammation in trauma patient.
Detailed description
Transfusion of blood products has many disadvantages. Erythropoietin is used to increase red blood cells production and decrease such disadvantages.In some studies anti inflammatory effects is shown for Erythropoietin.
One of the most problems in the intensive care unit is stress response. we are going to evaluate effects of erythropoietin on oxidative stress and inflammation in trauma patient in intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: erythropoietin |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All multiple trauma patients>16 years with informed consent
Key exclusion criteria (7 listed)
- Hypertension
- Allergy
- Erythroid leukemia
- Pregnancy and breast feeding
- Pre operative patient
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 |
|---|---|---|
| erythropoietinAlso: EPREX300mg/kg erythropoietin 3 times on the first week of admission | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
apachi 2 saps 30 days mortality
Time frame: untill discharge
1 secondary outcome
30 days mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
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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.
MOJTABA MOJTAHEDZADE study chair
TUMS
MOSTAFA MOHAMMADY principal investigator
TUMS
MOJTABA MOJTAHED study director
TUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erythropoietin in people with Multiple Trauma, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Nov 2010. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mojtaba mojtahedzade (0982166701041, Mojtahed@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apachi 2 saps 30 days mortality (time frame: untill discharge). 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 Nov 2010.