TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study (TETRAM2)
Primary Purpose
Spinal Trauma With Neurological Deficit
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Erythropoetin (rHuEPO, EPREX®)
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Trauma With Neurological Deficit focused on measuring Spinal trauma, erythropoietin, dose escalation study
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
Pulmonary embolism occurring during a 14 day delay following EPO injection.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00478517
Brief Title
TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study
Acronym
TETRAM2
Official Title
Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Withdrawn
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Trauma With Neurological Deficit
Keywords
Spinal trauma, erythropoietin, dose escalation study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Erythropoetin (rHuEPO, EPREX®)
Primary Outcome Measure Information:
Title
Pulmonary embolism occurring during a 14 day delay following EPO injection.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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,
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lieutaud, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study
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