Spinal Trauma With Neurological DeficitPhase 1TETRAM2NCT00478517
TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study
A Phase 1 study testing Erythropoetin (rHuEPO, EPREX®) in people with Spinal Trauma With Neurological Deficit, run by Hospices Civils de Lyon.
Trial summary
The social, psychological, economic burden of Spinal trauma with deficit is great, and there is no curative treatment. Erythropoetin (EPO) is promising, due to its neuroprotective effects demonstrated in vitro, in vivo in animal models and in a preliminary study including patients with stroke. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Spinal Trauma With Neurological Deficit
- What is being tested?
- Erythropoetin (rHuEPO, EPREX®)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2007to not given
- Phase
- Phase 1
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient, male or female, aged 15 to 65 years, covered by a social insurance system, having given an informed consent (or attested by a third person if unable to sign, or parents consent in minors), within 12 hours of a spinal trauma, without vital organ deficiency from a non spinal origin
Who cannot join
- Impaired consciousness,
- Treatment not given within 12 hours,
- Cervical arthritis,
- Respiratory failure requiring artificial ventilation,
- Patient requiring blood transfusion superior to 2 units,
- Uncontrolled severe hypertension,
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- Unstable hemodynamics,
- Patient suffering from epilepsy,
- Recent or uncontrolled angina pectoris,
- Having received high doses of glucorticoïds,
- Pregnant or breasting,
- With more than 15 g/ml of haemoglobin,
- With previous thrombo embolism disease,
- With allergy to Low molecular Weight heparin, or
- Participating in another interventional study
About this study
Official title: Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2
The social, psychological, economic burden of Spinal trauma with deficit is great, and there is no curative treatment.
Erythropoetin (EPO) is promising, due to its neuroprotective effects demonstrated in vitro, in vivo in animal models and in a preliminary study including patients with stroke.
Read more
The study primary end point is to find out the maximum tolerated dose of EPO. This is based on the occurrence of pulmonary embolism during a 14 day delay following EPO injection. Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid (CSF), study of EPO effects on several inflammatory and apoptotic bio markers and blood cell counts.
The experimental design is a dose scale study (600 to 2400 UI/Kg), using a single dose of rHuEPO, (EPREX®). The EPO dose is defined using a Bayesian continuous reassessment Method (CRM). The sample size is expected for less than 20 patients.
Eligible patients are patients aged 15 to 65 years, able to receive the EPO injection within 12 hours of a spinal trauma, without vital blood loss or associated diseases. The follow-up lasts 6 months.
- Conditions
- Spinal Trauma With Neurological Deficit
- Being tested
- Erythropoetin (rHuEPO, EPREX®)
- Keywords
- Spinal trauma, erythropoietin, dose escalation study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoetin (rHuEPO, EPREX®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary embolism occurring during a 14 day delay following EPO injection.
Secondary outcomes (1)
Blood cells count biomarkers of inflammation and apoptosis: measured at Day 0 (Epo antibodies) D1, D3 and D 14 ICAM-1 Fas-Ligant M-30 IL-10 in blood and CSF. Clinical ASIA score, morbi-mortality Evolution of spinal MRI between D0 and D28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Trauma With Neurological DeficitStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Lieutaud, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478517
- Sponsor's protocol ID
- 2006.455
- Acronym
- TETRAM2
- Status last verified
- Mar 2009
- First submitted
- 23 May 2007
- Last updated
- 11 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2
- ClinicalTrials.gov ID
- NCT00478517
- Acronym / sponsor ID
- TETRAM2 / 2006.455
- Conditions
- Spinal Trauma With Neurological Deficit
- Keywords
- Spinal trauma, erythropoietin, dose escalation study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 20 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2007
- First posted
- 24 May 2007 (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 social, psychological, economic burden of Spinal trauma with deficit is great, and there is no curative treatment.
Erythropoetin (EPO) is promising, due to its neuroprotective effects demonstrated in vitro, in vivo in animal models and in a preliminary study including patients with stroke.
The study primary end point is to find out the maximum tolerated dose of EPO. This is based on the occurrence of pulmonary embolism during a 14 day delay following EPO injection. Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid (CSF), study of EPO effects on several inflammatory and apoptotic bio markers and blood cell counts.
The experimental design is a dose scale study (600 to 2400 UI/Kg), using a single dose of rHuEPO, (EPREX®). The EPO dose is defined using a Bayesian continuous reassessment Method (CRM). The sample size is expected for less than 20 patients.
Eligible patients are patients aged 15 to 65 years, able to receive the EPO injection within 12 hours of a spinal trauma, without vital blood loss or associated diseases. The follow-up lasts 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient, male or female, aged 15 to 65 years, covered by a social insurance system, having given an informed consent (or attested by a third person if unable to sign, or parents consent in minors), within 12 hours of a spinal trauma, without vital organ deficiency from a non spinal origin
Key exclusion criteria (15 listed)
- Impaired consciousness,
- Treatment not given within 12 hours,
- Cervical arthritis,
- Respiratory failure requiring artificial ventilation,
- Patient requiring blood transfusion superior to 2 units,
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 |
|---|---|---|
| Erythropoetin (rHuEPO, EPREX®) | Drug | – |
Primary outcome
Pulmonary embolism occurring during a 14 day delay following EPO injection.
1 secondary outcome
Blood cells count biomarkers of inflammation and apoptosis: measured at Day 0 (Epo antibodies) D1, D3 and D 14 ICAM-1 Fas-Ligant M-30 IL-10 in blood and CSF. Clinical ASIA score, morbi-mortality Evolution of spinal MRI between D0 and D28.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
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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.
Thomas Lieutaud, MD principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erythropoetin (rHuEPO, EPREX®) in people with Spinal Trauma With Neurological Deficit, run by Hospices Civils de Lyon.
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 15 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: withdrawn, as of the sponsor's last update on 11 Mar 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pulmonary embolism occurring during a 14 day delay following EPO injection.. 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 11 Mar 2009.