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

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00478517

Purpose

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.

Condition	Intervention	Phase
Spinal Trauma With Neurological Deficit	Drug: Erythropoetin (rHuEPO, EPREX®)	Phase I

MedlinePlus related topics: Injuries Pulmonary Embolism Wounds

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment
Official Title:	Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Pulmonary embolism occurring during a 14 day delay following EPO injection.

Secondary Outcome Measures:

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.

Estimated Enrollment:	20
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478517

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Thomas Lieutaud, MD

Hospices Civils de Lyon

More Information

No publications provided

Study ID Numbers:	2006.455
Study First Received:	May 23, 2007
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00478517 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Spinal trauma
erythropoietin
dose escalation study

Study placed in the following topic categories:

Epoetin Alfa
Hematinics
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Therapeutic Uses
Hematologic Agents

Wounds and Injuries
Disorders of Environmental Origin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009