Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using NIRS (E-NESE)

Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using Near-Infrared Spectroscopy

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

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic; Acute Stroke; Thrombolytic Therapy
• Intervention / Treatment: Device: Near-infrared spectroscopy reading

Detailed Description

Acute ischemic stroke is characterized by cerebral vascular occlusion. Early thrombolytic therapy is an important way of treatment for these set of individuals. This condition is a serious cause of mortality and morbidity among the individuals who present to emergency department. Recombinant tissue plasminogen activator (rtPA) is the only proven treatment method in individuals with acute ischemic stroke in the first three hours. License for the use of intravenous rtPA in acute ischemic stroke in Turkey was given in 2006. Since then, no data of this drug has been submitted except for a few reports and papers.

In this study, investigators planned to evaluate the efficacy of rTPA treatment by evaluating cerebral perfusion; before, during and after in participants who will be treated with thrombolytic therapy. The evaluation will be done by using NIRS (Near-Infrared Spectroscopy) by means of non-invasively placed electrodes with readings of cerebral saturation measurement.

Individuals with acute ischemic stroke has being evaluated with NIHSS (National Institutes of Health Stroke Scale) and if appropriate, thrombolytic treatment decision is taken.Participants of this study will be selected from individuals who applied to Dokuz Eylül University Emergency Department due to acute ischemic stroke in one year period. These participants will be monitored noninvasively for routine cardiac and respiratory follow-up.

After informed voluntary consent form is signed, a non-invasive NIRS monitorization will be started due to readings from participants' forehead region. NIRS readings are harmless and does not interfere with the treatment therefore it is not possible to make any negative contribution to the treatment process via this study.

In this study, NIRS measurement results, follow-up parameters and participants' neurological status will be investigated. Participants to be treated with routine emergency thrombolytic therapy will be invastigated with near infrared spectroscopy. Routine scheduled treatment will not be intercepted or changed. The drugs to be used will be determined by the emergency department and neurology physician dealing with the participants' condition and not to be interfered by this study.

The medication and doses that the participants are scheduled to be administered by his / her physician will not be intervened in the manner and timing of the operation that requires it.

Because of the NIRS measurement is done with a simple electrode placed on forehead there will be no adverse effects on the examination nor treatment and it cannot interfere with routine approach of these therapy. In our study participants' vital parameters (blood pressure, heart rate, respiratory rate, sat O2), glasgow coma scale, NIRS values and NIHSS will be recorded during thrombolytic therapy at every 15 minutes (0.min, 15.min, 30min, 45min, 60min) and at 120 minutes. Furthermore NIRS values and imaging results will be recorded for investigation. In addition, if complications that may arise secondary to this treatment the complications' time and type will be obtained.

The obtained data will be recorded to and the results will be evaluated.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Turkey
  • Narlidere
    • Izmir, Narlidere, Turkey, 35320
      • Dokuz Eylul University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assesment of complications with NIRS	if any complications of thrombolytic therapy occurs during treatment, time and type of those complications and NIRS readings of that time will be recorded to see if there is any correlation	During thrombolytic treatment (60 minutes)

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Study Director: Nese Colak Oray, MD

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: August 4, 2018
• First Submitted That Met QC Criteria: August 4, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: acute ischemic stroke; thrombolytic therapy; near infrared spectroscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: 405-SBKAEK; 2018.KB.SAG.062 (Other Grant/Funding Number: Dokuz Eylul University Scientific Research Project Support)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No