An observational study in Acute Stroke, Thrombolytic Therapy and Stroke, Ischemic, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by Dokuz Eylul University · Observational
Investigators aim to study effectiveness of systemic thrombolytic therapy on acute ischemic stroke patients with near infrared spectroscopy.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 41 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Non-invasive readings will be taken from forehead with near-infrared spectroscopy
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
Time frame: 120 minutes
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
Time frame: During thrombolytic treatment (60 minutes)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dokuz Eylul University