Thrombolysis in Ischemic Spinal Cord Stroke

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02242084
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 35.8
• Patients Per Site Per Month: 0.3

Study Details

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:

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

Study Design

• Study Type: Interventional
• 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: Apr 1, 2016
• Actual Primary Completion Date: Mar 26, 2019
• Actual Study Completion Date: Mar 26, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Modified Ranking Scale (mRS) [3 month post thrombolysis]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petach Tiqva	Hamerkaz	Israel	49100

Sponsors and Collaborators

• Rabin Medical Center

Investigators

• Principal Investigator: Israel Steiner, Professor, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: israel Steiner, Head of Neurology Department, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT02242084
• Other Study ID Numbers: AK 23 - 14
• First Posted: Sep 16, 2014
• Last Update Posted: Mar 28, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Intestinal Diseases; Urinary Retention; Tissue Plasminogen Activator

Study Results

No Results Posted as of Mar 28, 2019