Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using Near-Infrared Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Continuous Near Infrared Spectroscopy reading during thrombolytic therapy
研究概览
简要总结
Investigators aim to study effectiveness of systemic thrombolytic therapy on acute ischemic stroke patients with near infrared spectroscopy.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient presented to emergency deparment with acute stroke who undergoes thrombolytic therapy
- •Patients with age over 18 years old
排除标准
- •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)
结局指标
主要结局
Continuous Near Infrared Spectroscopy reading during thrombolytic therapy
时间窗: 120 minutes
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
次要结局
- Assesment of complications with NIRS(During thrombolytic treatment (60 minutes))
研究者
Dr Emre Sanci
Emergecy Medicine Doctor
Dokuz Eylul University