Acute spinal cord injury
Conditions
Interventions
Intervention type:DRUG
Name of intervention:filgrastim
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAVENOUS DRIP
Dose per administration
Sponsors
Coordinating Committee
Chiba University Hospital
University of Tsukuba Hospital
Niigata University Medical & Dental Hospital
Kanazawa Medical University Hospital
Dokkyo Medical University
Tsukuba Medical Center Hospital
Funabashi Municipal Medical Center
Chiba Rosai Hospital
Kimitsu Chuo Hospital
Tokai University Hospital
Hamamatsu University Hospital
Mie University Hospital
Japanese Red Cross Kobe Hospital
Hiroshima University Hospital
Nagasaki Rosai Hospital
Chubu Rosai Hospital
Tohoku University Hospital
Gifu Unive
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) AIS Grade is B or C at screening (2) AIS Grade is B or C at re-assessment of neurological status 48 hours (plus-minus 4 hours) after the injury (3) Neurological level of injury is between C4 and C7 (4) Age betweem 16-85 (5) Patients who give informed consent to participate in the present trial (6) Patients who can visit 3 months, 6 months, and 12 months after administration
Exclusion criteria
Exclusion criteria: (1) Allergy to filgrastim. (2) Hematologic malignancy or its previous history (3) Malignant disease under treatment (4) invasive treatment for myocardial infarction or angina pectoris within 6 months (5) previous history of rombosis (6) splenomegaly. (7) consciousness disorder. (8) Patients who are pregnant women, are willing to become pregnant in study period or are lactation. (9) Neurological disorder which can affect neurological evaluation in the present trial (10) Patients who receive filgrastim or methylprednisolone sodium succinate after the injury (11) Patients who are expected to have rapid worsening of symptoms during the trial period (12) Patients with serious complications (13) Patients who can not start the rehabilitation in early by complications (14) Patients with advanced dementia or mental illness (15) Patients who can not start the rehabilitation in early by multiple trauma or organ damage (16) Patients who have fracture of extremities, the spine, or the other parts which can affect neurological evaluation in the present trial (17) Patients who are participating in other trials, or received other study drugs within 12 weeks (18) In addition, the patient whom investigator judged to be unsuitable as a patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transition of motor paralysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Change in motor paralysis Change in sensory paralysis Degree of dysfunction associated with paralysis Proportion of responderpatients that respond to the treatment Neurological level of injury Activity of daily living Quality of Life Safety: Frequency of adverse events | — |
Countries
Japan
Contacts
Public ContactTadami Fujiwara
Chiba University Hospital
Outcome results
None listed