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Thrombolysis in Ischemic Spinal Cord Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02242084
Recruitment Status : Terminated
First Posted : September 16, 2014
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
israel Steiner, Rabin Medical Center

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:

  1. Dissection of the aorta.
  2. Aneurism in the aorta.
  3. Atherosclerotic disease of the aorta or vertebral arteries.
  4. Spinal surgeries.
  5. Spinal AVM.
  6. Embolism from cardiac origin.
  7. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: Alteplase treatment
All subject who enter the trial will receive treatment with Alteplase along with questionnaire.
Drug: Intravenuse Alteplase



Primary Outcome Measures :
  1. Modified Ranking Scale (mRS) [ Time Frame: 3 month post thrombolysis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with vascular risk factors
  2. Patients with sudden weakness of the lower or upper limbs together with bowel disorder.
  3. Window treatment - not over 6 hours since the start of the event till the start of the treatment.
  4. Patient without dissection of the aorta in the abdomen.
  5. Patient without contraindication to IVtPA.
  6. 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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Information from the National Library of Medicine

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


Locations
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Israel
Rabin Medical Center
Petach Tiqva, Hamerkaz, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Israel Steiner, Professor Rabin Medical Center
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Responsible Party: israel Steiner, Head of Neurology Department, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02242084    
Other Study ID Numbers: AK 23 - 14
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Intestinal Diseases
Urinary Retention
Urination Disorders
Urologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action