Thrombolysis for Acute Ischemic Stroke Facilitated by TeleStroke: Oman TeleStroke Initiative
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- 90 day outcome
研究概览
简要总结
The goal of this study is to establish and examine the efficacy of using a Telestroke network in Oman to facilitate using emergent thrombolysis for patients with acute ischemic stroke encountered in selected peripheral hospitals. It is proposed to establish a TeleStroke network involving two central hospitals in Muscat linked to three to five peripheral hospitals in Oman which currently have access to CT scans and basic infrastructure for management of AIS patients- but do not have a Neurology service. Selected staff from Internal Medicine/Emergency Medicine departments, Nursing, Technical service and support staffs will be trained in the process of assessment and management of AIS patients including the use of IV alteplase or tenecteplase. They will also be trained in timely access of a Neurologist on call at the central hospital(s) using a TeleStroke network. The Neurologist would conduct a Telestroke based clinical assessment of the AIS patient, review imaging and laboratory results in a timely manner and advice the medical team at the peripheral hospital regarding administration of IV alteplase/tenecteplase. The main purpose of such consultation would be to recognize eligible patients for administration of IV thrombolysis safely at the earliest opportunity within 4.5 hours, leading to increased rates of such thrombolysis with expected improved outcomes. Outcomes would be compared among 100 patients with AIS managed across these 5 hospitals prior to initiation of the practice of thrombolysis and at least 100 patients treated each with IV alteplase using TeleStroke Consultation with Neurologist. Demonstration of efficacy of TeleStroke based stroke thrombolysis would lead to effective implementation of this practice in Oman.
详细描述
Stroke is the second leading cause of death globally and the primary cause of long-term disability. Timely management of acute ischemic stroke (AIS) requires emergent administration of intravenous thrombolytics (alteplase or tenecteplase) within 4.5 hours of symptom onset, often followed by triage for possible thrombectomy. However, many peripheral hospitals, particularly in regions like Oman, lack the specialized neurological expertise necessary for this time-sensitive management.
Telemedicine, specifically 'TeleStroke,' has emerged as a crucial solution in numerous countries and communities to bridge this gap, enabling remote neurological support for acute stroke thrombolysis. The Oman TeleStroke Initiative aims to establish and evaluate the efficacy of such a network.
Study Objectives:
This study aims to:
Establish a TeleStroke 'hub' center within one or two major hospitals in Muscat with existing neurologic services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor at 90 days would be masked and unaware of initial intervention arm in which the patient was.
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
- •Age >18 years. Acute neurologic deficits due to cerebral ischemia/infarction. Clearly defined onset with duration from stroke onset of <4.5 hours. Significant neurological deficit (usually NIHSS score of 4-25).
排除标准
- •CT brain shows showing evidence of intracranial hemorrhage
- •CT brain showing acute or subacute infarct of size about >1/3 Middle Cerebral Artery territory.
- •Arterial puncture at non compressible site in previous 7 days
- •History of previous intracranial hemorrhage.
- •Intracranial neoplasm, AV malformation, or aneurysm
- •Recent head injury OR intracranial or intraspinal surgery in last 3 mo.
- •Persistent Elevated BP >185/110 mm Hg despite treatment.
- •Active ongoing internal bleeding.
- •Platelet count <100 000/mm
- •Current use of NOACs OR warfarin with INR >1.7 OR Inj.Enoxaparin/Heparin in therapeutic dose
- •Blood glucose concentration <2.7mmol/L (<50mg/dl).
- •Relative contraindications: (may consider IV alteplase on individual evaluation).
- •Seizure at onset with post ictal residual neurological deficit.
- •Signs of mild stroke in isolation or rapidly improving symptoms.
- •Pregnancy.
- •Recent GI or UT hemorrhage within the last 21 days.
- •Recent MI within previous 3 months (to exclude anterolateral infarct / STEMI)
结局指标
主要结局
90 day outcome
时间窗: 90 days
Clinical outcome on modified Rankin Score at 90 days. This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.
Discharge Outcome
时间窗: At discharge (assessed up to 5 days)
Clinical outcome on modified Rankin Score at discharge from hospital (assessed up to 5 days). This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.
Rate of Thrombolysis
时间窗: At admission and initial management- 2 hours
Rate of utilization of IV alteplase / tenecteplase thrombolysis for acute ischemic stroke at peripheral hospitals
次要结局
- Intracranial Hemorrhage Rate(24 hours)
- Door to Needle time(1 hour)