NCT00561067

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

November 19, 2007

Last Update Submit

March 13, 2019

Conditions

Spinal Cord Injury

Keywords

Spinal cord injuryspinal shockerythropoietin

Outcome Measures

Primary Outcomes (1)

  • Improvement of ASIA Impairment Scale of at least 1 grade. Score on ASIA Scale and a ASIA Impairment Scale are an inclusion criteria, then at 3rd, 7th, 14th, 30th, 60th, 90th days

    3 months

Secondary Outcomes (3)

  • Increase of ASIA motor/sensory scores at 3rd, 7th, 14th, 30th, 60th, 90th days

    3 months

  • Functional autonomy with SCIM scores at 7th, 30th, 60th, 90th days

    3 months

  • Spasticity with the Ashworth Scale, spasms with the PENN Scale and neurogenic pain with the VAS Scale at 7th, 14th days

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Methylprednisolone

Drug: Methylprednisolone

2

EXPERIMENTAL

Erythropoietin

Drug: Erythropoietin

Interventions

ErythropoietinDRUG

EPO 500 IU/kg diluted in 50 ml saline and infused in 30 minutes; treatment is started within eight hours after the spinal injury; the same drug dosage will be infused at 24 and 48 hours

2
MethylprednisoloneDRUG

MP 30 mg/kg intravenous (iv) in the first hour, followed by 5.4 mg/kg/h for 23 hours if treatment is started within three hours after the spinal injury,or for 48 hours if treatment is started between three and eight hours (protocol NASCIS III, National Acute Spinal Cord Injury Study)

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.O. Ospedale Ca' Granda

Milan, 20162, Italy

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

ErythropoietinMethylprednisolone

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tiziana Redaelli, MD

    Azienda Ospedaliera Ospedale Niguarda Ca' Granda Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

April 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

IT(1)