Thrombolysis in Ischemic Spinal Cord Stroke

NCT ID: NCT02242084

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-03-26

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.

Conditions

Motor Weakness in Two or Four Limbs; Damage in the Anterior Spinal Artery (ASA); Temperature and Superficial Sensation; Urinary Retention or Bowel Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alteplase treatment

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

Group Type: EXPERIMENTAL

Intravenuse Alteplase

Intervention Type: DRUG

Interventions

Intravenuse Alteplase

Intervention Type: DRUG

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.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

israel Steiner

Head of Neurology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Israel Steiner, Professor

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petach Tiqva, Central District, Israel

Countries

Israel

Other Identifiers

AK 23 - 14

Identifier Type: -

Identifier Source: org_study_id