Thrombolysis in Ischemic Spinal Cord Stroke

NCT02242084 | Terminated Phase 2

• 1 other identifier: AK 23 - 14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 1.Dissection of the aorta.
2. 2.Aneurism in the aorta.
3. 3.Atherosclerotic disease of the aorta or vertebral arteries.
4. 4.Spinal surgeries.
5. 5.Spinal AVM.
6. 6.Embolism from cardiac origin.
7. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Modified Ranking Scale (mRS)

  3 month post thrombolysis

Study Arms (1)

Alteplase treatment

EXPERIMENTAL

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

Drug: Intravenuse Alteplase

Interventions

Intravenuse Alteplase DRUG

Alteplase treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with vascular risk factors
• Patients with sudden weakness of the lower or upper limbs together with bowel disorder.
• Window treatment - not over 6 hours since the start of the event till the start of the treatment.
• Patient without dissection of the aorta in the abdomen.
• Patient without contraindication to IVtPA.
• Patient with no etiology found after clarification.

You may not qualify if:

• \. Refusal to sign an ICF. 2. Reason for weakness is known. 3. Patient with contraindication IVtPA.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petach Tiqva, Central District, 49100, Israel

Location

MeSH Terms

Conditions

Urinary Retention; Intestinal Diseases

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Israel Steiner, Professor

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology Department

Study Record Dates

• First Submitted: September 14, 2014
• First Posted: September 16, 2014
• Study Start: April 1, 2016
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

IL (1)