Evaluation of Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative Study Versus Methylprednisolone (MP)

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the tolerability and efficacy of erythropoietin (EPO) treatment in spinal shock in comparison with the methylprednisolone treatment (MP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Niguarda Hospital
• Treatments: Epoetin Alfa; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Traumatic SCI occurred within 8 hours

• Hemodynamic stability at the time of treatment start (systolic blood pressure > 90 mmHg for at least 1 hour without massive infusion or vasopressor support for ongoing bleeding)

• Neurological level between C5 and T12 (ASIA scale)

• ASIA Impairment Scale: A or B

• Informed consent

Exclusion Criteria:

• SCI other than traumatic

• SCI caused by edged weapons or fire arms

• Traumatic SCI after 8 hours

• Neurological level above C5 or below T12

• ASIA Impairment Scale C, D, E

• Uncontrolled arterial hypertension

• Past or current cerebrovascular disease

• Past or current acute myocardial infarction

• History of thrombotic events

• Other chronic cardiovascular disorders (cardiac arrhythmias, congestive heart failure)

• History of peripheral arterial disease, polycythemia, porphyria, active malignancy

• Previous or current neurological diseases with abnormal neurological examination

• Suspected or definite pregnancy or lactation (requiring ßHCG confirmation)

• Clinically relevant psychiatric disease

• Known allergy to EPO

• Hypersensitivity to human albumin

• Acute or chronic renal failure