TETRAM 2. 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.
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.
|Spinal Trauma With Neurological Deficit||Drug: Erythropoetin (rHuEPO, EPREX®)||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2|
- Pulmonary embolism occurring during a 14 day delay following EPO injection.
- 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.
|Study Start Date:||May 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478517
|Principal Investigator:||Thomas Lieutaud, MD||Hospices Civils de Lyon|