PARAPLEGICS AND TETRAPLEGICS MedDRA version: 9.1 Level: LLT Classification code 10041552 Term: Spinal cord injury
Conditions
Interventions
Trade Name: EPREX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration num
Sponsors
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: 18-65 years; Traumatic SCI occurred within 8 hours Hemodinamic 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if EPO is better than MP in improving the clinical outcome of traumatic SCI in a clinically relevant, measurable way (ASIA Impairment Scale);Secondary Objective: 1. To assess the safety of EPO compared to MP, in terms of number of treatment-emergent adverse events, serious adverse events, and events leading to treatment withdrawal; 2. To assess the effects of the two treatments on the spinal motor and/or sensory functions (ASIA Scale); 3. To assess the effects of the two treatments on measures of functional autonomy (Spinal Cord Independence Measure Scale, SCIM); 4. To assess the influence of the two treatments on measures of spasticity and spasms (Ashworth and PENN Scales); 5. To assess the effects of the two treatments on neurogenic pain (VAS Scale); 6.To assess the impact of the two treatments on surrogate end-points (Somatosensory Evoked Potentials, SEP; Magnetic Resonance Imaging, MRI);Primary end point(s): Improvement of the ASIA Impairment Scale of at least one grade | — |
Countries
Italy
Outcome results
None listed