Stroke, Ischemic Clinical Trial
Official title:
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.
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.
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