Thrombolysis in Ischemic Spinal Cord Stroke

Brief Title

Thrombolysis in Ischemic Spinal Cord Stroke

Official Title

Thrombolysis in Ischemic Spinal Cord Stroke

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Modified Ranking Scale (mRS)


Condition

Motor Weakness in Two or Four Limbs

Intervention

Intravenuse Alteplase

Study Arms / Comparison Groups

 Alteplase treatment
Description:  All subject who enter the trial will receive treatment with Alteplase along with questionnaire.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

April 2016

Completion Date

March 26, 2019

Primary Completion Date

March 26, 2019

Eligibility 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.

        -
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Israel Steiner, Professor, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02242084

Organization ID

AK 23 - 14


Responsible Party

Principal Investigator

Study Sponsor

Rabin Medical Center


Study Sponsor

Israel Steiner, Professor, Principal Investigator, Rabin Medical Center


Verification Date

March 2019