Thrombolysis in Ischemic Spinal Cord Stroke
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|ClinicalTrials.gov Identifier: NCT02242084|
Recruitment Status : Terminated
First Posted : September 16, 2014
Last Update Posted : March 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Motor Weakness in Two or Four Limbs Damage in the Anterior Spinal Artery (ASA) Temperature and Superficial Sensation Urinary Retention or Bowel Disorder||Drug: Intravenuse Alteplase||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thrombolysis in Ischemic Spinal Cord Stroke|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||March 26, 2019|
|Actual Study Completion Date :||March 26, 2019|
Experimental: Alteplase treatment
All subject who enter the trial will receive treatment with Alteplase along with questionnaire.
Drug: Intravenuse Alteplase
- Modified Ranking Scale (mRS) [ Time Frame: 3 month post thrombolysis ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242084
|Rabin Medical Center|
|Petach Tiqva, Hamerkaz, Israel, 49100|
|Principal Investigator:||Israel Steiner, Professor||Rabin Medical Center|