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

Spinal Trauma With Neurological Deficit Clinical Trial

— TETRAM2  

Official title:

Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00478517
• Other study ID #: 2006.455
• Status: Withdrawn
• Phase: Phase 1
• First received: May 23, 2007
• Last updated: March 10, 2009
• Start date: May 2007

Study information

• Verified date: March 2009
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurologic Manifestations
• Spinal Trauma With Neurological Deficit
• Wounds and Injuries

Intervention

Drug:
• Erythropoetin (rHuEPO, EPREX®)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary embolism occurring during a 14 day delay following EPO injection.
Secondary	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.