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Thrombolysis in Ischemic Spinal Cord Stroke

NCT02242084 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-03-28

No results posted yet for this study

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

Interventions

DRUG

Intravenuse Alteplase

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Israel Steiner, Professor · Rabin Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-03-26
Completion
2019-03-26

Countries

  • Israel

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02242084 on ClinicalTrials.gov