Thrombolysis in Ischemic Spinal Cord Stroke

Phase 2

Terminated

• Conditions: Motor Weakness in Two or Four Limbs; Damage in the Anterior Spinal Artery (ASA); Temperature and Superficial Sensation; Urinary Retention or Bowel Disorder
• Interventions: Drug: Intravenuse Alteplase

• Registration Number: NCT02242084
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-14
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Study Start: 2016-04
• Status Verified: 2019-03
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alteplase treatment	Intravenuse Alteplase	All subject who enter the trial will receive treatment with Alteplase along with questionnaire.

Primary Outcome Measures

Name	Time	Method
Modified Ranking Scale (mRS)	3 month post thrombolysis

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tiqva, Hamerkaz, Israel