Spinal Trauma With Neurological Deficit Clinical Trial
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.
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.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment