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TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study

NCT00478517 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-03-11

No results posted yet for this study

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.

Conditions

  • Spinal Trauma With Neurological Deficit

Interventions

DRUG

Erythropoetin (rHuEPO, EPREX®)

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Thomas Lieutaud, MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00478517 on ClinicalTrials.gov