Damage in the Anterior Spinal Artery (ASA) Clinical Trial
Official title:
Thrombolysis in Ischemic Spinal Cord Stroke
| Verified date | March 2019 |
| Source | Rabin Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | March 26, 2019 |
| Est. primary completion date | March 26, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rabin Medical Center | Petach Tiqva | Hamerkaz |
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Modified Ranking Scale (mRS) | 3 month post thrombolysis |