Thrombolysis in Ischemic Spinal Cord Stroke
Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (CNS). In most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%.
Ischemic stroke of the spinal cord can arise from:
- Dissection of the aorta.
- Aneurism in the aorta.
- Atherosclerotic disease of the aorta or vertebral arteries.
- Spinal surgeries.
- Spinal AVM.
- Embolism from cardiac origin.
- Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in hours until the patient becomes paralyzed in two or in all four limbs. In most cases the damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor weakness accompanied by disturbance of temperature and superficial sensation, urinary retention or bowel disorder, with preserved position and vibration sense.
The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS). Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the spinal cord is necessary upon arrival in the emergency department.
One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and validated in numerous studies for ischemic events in the brain, until today no validated study in ischemic spinal stroke using thrombolysis has been completed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Hamerkaz
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Petach Tiqva, Hamerkaz, Israel, 49100
- Rabin Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with vascular risk factors
- Patients with sudden weakness of the lower or upper limbs together with bowel disorder.
- Window treatment - not over 6 hours since the start of the event till the start of the treatment.
- Patient without dissection of the aorta in the abdomen.
- Patient without contraindication to IVtPA.
- Patient with no etiology found after clarification.
Exclusion Criteria:
1. Refusal to sign an ICF. 2. Reason for weakness is known. 3. Patient with contraindication IVtPA.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Alteplase treatment
All subject who enter the trial will receive treatment with Alteplase along with questionnaire.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Modified Ranking Scale (mRS)
Time Frame: 3 month post thrombolysis
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3 month post thrombolysis
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Israel Steiner, Professor, Rabin Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK 23 - 14
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