Thrombolysis in Ischemic Spinal Cord Stroke
Primary Purpose
Motor Weakness in Two or Four Limbs, Damage in the Anterior Spinal Artery (ASA), Temperature and Superficial Sensation
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Intravenuse Alteplase
Sponsored by
About this trial
This is an interventional treatment trial for Motor Weakness in Two or Four Limbs
Eligibility Criteria
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.
-
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alteplase treatment
Arm Description
All subject who enter the trial will receive treatment with Alteplase along with questionnaire.
Outcomes
Primary Outcome Measures
Modified Ranking Scale (mRS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02242084
First Posted
September 14, 2014
Last Updated
March 26, 2019
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02242084
Brief Title
Thrombolysis in Ischemic Spinal Cord Stroke
Official Title
Thrombolysis in Ischemic Spinal Cord Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Weakness in Two or Four Limbs, Damage in the Anterior Spinal Artery (ASA), Temperature and Superficial Sensation, Urinary Retention or Bowel Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alteplase treatment
Arm Type
Experimental
Arm Description
All subject who enter the trial will receive treatment with Alteplase along with questionnaire.
Intervention Type
Drug
Intervention Name(s)
Intravenuse Alteplase
Primary Outcome Measure Information:
Title
Modified Ranking Scale (mRS)
Time Frame
3 month post thrombolysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Steiner, Professor
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tiqva
State/Province
Hamerkaz
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Thrombolysis in Ischemic Spinal Cord Stroke
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