NCT00901381

Brief Summary

The aim of the study is to investigate treatment with Leukostim (Filgrastim; granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

1.7 years

First QC Date

May 12, 2009

Last Update Submit

January 6, 2014

Conditions

Ischemic Stroke

Keywords

Ischemic strokeStem cellsColony-stimulating factorsFilgrastimRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Dependence assessed by the modified Rankin scale

    180 day

Secondary Outcomes (4)

  • Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale

    180 day

  • Disability assessed by the Barthel Index and Glasgow Outcome Scale

    180 day

  • Infarct size assessed by the magneto-resonance imaging

    180 day

  • Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events

    Duration of study

Study Arms (2)

G-CSF

EXPERIMENTAL
Drug: Filgrastim

Control

NO INTERVENTION

Interventions

FilgrastimDRUG

10 µg/kg subcutaneously once daily x 5 days

Also known as: Leukostim
G-CSF

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40 to 70 years old
  • CT/MRI confirmed ischemic stroke in carotid area during 48 hours after the onset of clinical signs
  • Level of conscious lower than 15 and higher than 8 points by the Glasgow Coma Scale
  • Acute extremity paresis lower than 4 points by Medical Research Consul scale

You may not qualify if:

  • Premorbid dependency (modified Rankin Scale \> 0)
  • Intracerebral hemorrhage
  • Transitory ischemic attack
  • Patients with previous stroke
  • Any disorders, that can affect interpretation of results (e.g. psychiatric or movement disorders)
  • Hematological diseases
  • Coagulopathy
  • Malignancy
  • Pregnancy and lactation
  • Organ dysfunction that would preclude tests required for this study
  • Known allergic reaction to G-CSF or a component of G-CSF
  • Patients that have received a cytokine within the last 1 month or are currently receiving a cytokine treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Institute of the Brain

Yekaterinburg, 620026, Russia

Location

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Andrey A Belkin, MD, PhD.

    Clinical Institute of the Brain, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

June 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

RU(1)