Overview

Methylprednisolone Given by 24-Hour or 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

OBJECTIVES: I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone (MePRDL) versus tirilazad for patients with acute spinal cord injury. II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator:

Yale University

Treatments:

Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Tirilazad

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Acute spinal cord injury; diagnosis confirmed by study physician using National Acute
Spinal Cord Injury Study neurologic exam

Glasgow Coma Score greater than 9

Randomization within 6 hours of injury required; treatment must begin within 8 hours of
injury

No root involvement only; no cauda equina only

--Prior/Concurrent Therapy--

Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed

--Patient Characteristics--

Hematopoietic: No hematologic contraindication to protocol therapy

Cardiovascular: No vascular contraindication to protocol therapy

Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening
co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No
patients under indictment or incarcerated; No conditions that would complicate follow-up,
e.g.: out-of-state residency or illegal alien status