Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using NIRS

NCT03621917 | Completed FDA Device

• 2 other identifiers: 405-SBKAEK2018.KB.SAG.062
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators aim to study effectiveness of systemic thrombolytic therapy on acute ischemic stroke patients with near infrared spectroscopy.

Conditions

Acute Stroke; Thrombolytic Therapy; Stroke, Ischemic

Keywords

near infrared spectroscopy; acute ischemic stroke; thrombolytic therapy

Outcome Measures

Primary Outcomes (1)

• Continuous Near Infrared Spectroscopy reading during thrombolytic therapy

  Patients who are undergoing thrombolytic medication (which takes 1 hour) will be Monitored with NIRS device and neurological findings and device readings will be investigated afterwards, to show/if clinical changes are correlated with readings

  120 minutes

Secondary Outcomes (1)

• Assesment of complications with NIRS

  During thrombolytic treatment (60 minutes)

Interventions

Near-infrared spectroscopy reading DEVICE

Non-invasive readings will be taken from forehead with near-infrared spectroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient admited who are over 18 years old and having treated with thrombolytic due to acute ischemic stroke at Dokuz Eylul University Hospital Izmir/Turkey during one year period (15/11/2017 - 15/11/2018)

You may qualify if:

• Any patient presented to emergency deparment with acute stroke who undergoes thrombolytic therapy
• Patients with age over 18 years old

You may not qualify if:

• Not accepting to be included to study (including during study)
• Patients who NIRS monitoring cannot be performed for any reason (device being occupied, the absence of a practicing team, etc.)
• Patients with (hematoma, mass etc.) skin lesions in the forehead region (electrode placement site)
• Patients with jaundice on skin (which can interfere with device readings)

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University Hospital

Izmir, Narlidere, 35320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nese Colak Oray, MD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergecy Medicine Doctor

Study Record Dates

• First Submitted: August 4, 2018
• First Posted: August 9, 2018
• Study Start: November 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

TU (1)