Clinical trial NCT00478517: TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study
Official title: Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Spinal Trauma With Neurological Deficit
Keywords: Spinal trauma
erythropoietin
dose escalation study
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2007-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pulmonary embolism occurring during a 14 day delay following EPO injection.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Thomas Lieutaud, MD
role: PRINCIPAL_INVESTIGATOR
References: