TETRAM 2. Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study (TETRAM2)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00478517
First received: May 23, 2007
Last updated: March 10, 2009
Last verified: March 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit, Maximum Tolerated Dose Study. TETRAM2

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00478517     History of Changes
Other Study ID Numbers: 2006.455
Study First Received: May 23, 2007
Last Updated: March 10, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Spinal trauma
erythropoietin
dose escalation study

Additional relevant MeSH terms:
Wounds and Injuries
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014