Helping Stroke Patients With ThermoSuit Cooling
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Feasibility of cooling as indicated by percentage of patients cooled to target within 1 hour of start of cooling
研究概览
简要总结
The aim of this study is to assess the feasibility of using the Life Recovery Systems ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke. This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke at four clinical centers. Subjects will receive hypothermia plus conventional therapy (such as IV-tPA and/or neurothrombectomy therapies if indicated). Endpoints will include feasibility of cooling, adverse events, and neurological recovery in comparison with matched historical controls.
详细描述
Patients presenting to the emergency department with clinical signs and symptoms of acute ischemic stroke will undergo initial evaluation. The patient will be screened for study eligibility. A medical history and list of active medications will be documented. A physical will be conducted including the patient's temperature, hemodynamic and neurological status (NIHSS score), 12-lead ECG, and routine baseline laboratory values including magnesium, CBC, BMP, coagulation parameters, CK, CK-MB, and Troponin I. If all inclusion criteria and no exclusion criteria are present, a member of the research team will consult the patient's attending physician for permission to approach the patient. If he/she agrees, a member of the team will inform the patient or guardian about the study's purpose and obtain written informed consent. A screening log will be kept of all patients screened for this study and the reasons they were not enrolled.
Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Hypothermia will generally be initiated in the ED or ICU, as soon as possible after the informed consent has been obtained. However, in cases in which neurothrombectomy is indicated and judged by the investigators to be feasible to start within 90 minutes of enrollment, cooling will be delayed until its completion, and shall afterward be initiated as soon as possible. In all cases the patient will be placed in the LRS ThermoSuit in the supine position.
Cooling will be started as specified in the Operator's Manual for the ThermoSuit device. Core temperature will be measured and monitored through a nasopharyngeal or esophageal temperature probe.
Cooling will be initiated by circulating ice-cold water (0-8°C ± 2.0°C) through the ThermoSuit, and the start time will be recorded. Patient core and TSS water temperatures will be electronically recorded. The patient will be cooled until the core temperature reaches between 32°C to 34°C. This will require approximately 5 to 20 minutes of cooling by the ThermoSuit device (not expected to be more than 30 minutes). Arterial blood pressure and heart rate will be recorded every 5 minutes from the baseline just before the start of cooling until 30 minutes after the cooling has started.
The clinician will be prompted by the automated monitor to purge the fluid from the suit when the patient's core temperature reaches approximately 33.5°C. The purging will take approximately 2 minutes. Start and stop times of purging will be recorded. The patient's body temperature should continue to decrease and then stabilize within the target range. The time at which the core temperature reaches 34°C will be recorded.
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
- Double (Participant, Outcomes Assessor)
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
- •Ischemic cortical stroke with NIHSS > _5_;
- •Treatment must be initiated within 8 hours from known time of symptom onset or, for eligible patients under the current AHA Guidelines, within the extended time window for mechanical thrombectomy of up to 24 hours.
- •Patient dimension criteria: Height: 147-190 cm (58 - 75 in) Width: ≤66 cm (26 in) (elbow to elbow).
排除标准
- •Sepsis (bacteremia and clinical syndrome within 72 h);
- •Known preexisting coagulopathy, (INR > 1.3, PTT >1.5 x control), active bleeding of unknown cause, immune compromised state, thrombocytopenia (platelet count < 160,000/mm), and history of cold agglutinin disease;
- •Hemodynamically significant cardiac dysrhythmias (eg. QTc interval >450 msec, bradycardia (heart rate less than 50), Mobitz Type II second degree AV block (or higher AV block), and severe ventricular dysrhythmias (sustained VT or VF) ) which cause significant hypotension (SBP ≤ 120 mmHg requiring more than two pressor medications);
- •Preexistent illness with life expectancy <6 months;
- •Pregnancy;
- •Rapidly improving symptoms;
- •Melena, or gross hematuria;
- •Sickle cell disease;
- •Temperature < 35°C on admission to Emergency Department;
- •Recent (< 1 week) incisions;
- •Any intracerebral hemorrhage;
- •A history of a brain vascular lesion (e.G. aneurism or arteriovenous malformation);
- •A history of brain disease or damage (e.g. neoplasm or dementia);
- •Patients receiving IV tPA > 3 hours from stroke onset;
- •Bradycardia (heart rate ≤ 50);
- •High degree AV block;
- •Ventricular tachycardia;
- •Ventricular fibrillation.
- •Significant hypotension < 120 mm Hg, regardless of the underlying cause
- •Exclusions for Patients to receive IV tPA :
- •Suspicion of subarachnoid hemorrhage on pretreatment evaluation, even with normal neuroimaging;
- •Systolic blood pressure greater than 185 mm of Hg or diastolic blood pressure >110 mmHg at the time of t-PA infusion and/or patient requires aggressive treatment to reduce blood pressure to within these limits;
- •Seizure at onset of stroke;
- •Active internal bleeding;
- •Known bleeding diathesis, including but not limited to:
- •Platelet count less than 100,000/mm3
- •Heparin during the preceding 48 hours and elevated aPTT (greater than upper limit of normal for laboratory)
- •Current use of oral anticoagulants (ex: warfarin) and INR >1.7;
- •Current use of direct thrombin inhibitors or direct factor Xa inhibitors
- •Elevated prothrombin time (PT) greater than 15 seconds.
- •Major surgery or other serious trauma during preceding 14 days;
- •Intercranial or intraspinal surgery, stroke, serious head trauma during preceding 3 months;
- •Recent arterial puncture at a non-compressible site;
- •Recent lumbar puncture during preceding 7 days;
- •History of intracranial hemorrhage, neoplasm, arteriovenous malformation, or aneurysm;
- •Recent Acute Myocardial Infarction
- •Abnormal blood glucose (<50 or >400 mg/dL)
- •Suspected/confirmed endocarditis
- •Exclusions for Patients Receiving Neurothrombectomy >
- •Patients with known hypersensitivity to nickel-titanium
- •Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the revascularization device
- •Patients with angiographic evidence of carotid dissection
研究组 & 干预措施
ThermoSuit Cooling Induction
Induction of therapeutic hypothermia (32-34 degrees C) using the LRS ThermoSuit System. Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Neurothrombectomy will be performed if indicated.
干预措施: ThermoSuit Cooling Induction (Device)
ThermoSuit Cooling Induction
Induction of therapeutic hypothermia (32-34 degrees C) using the LRS ThermoSuit System. Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Neurothrombectomy will be performed if indicated.
干预措施: Magnesium Sulfate (Drug)
ThermoSuit Cooling Induction
Induction of therapeutic hypothermia (32-34 degrees C) using the LRS ThermoSuit System. Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Neurothrombectomy will be performed if indicated.
干预措施: tPA (Drug)
ThermoSuit Cooling Induction
Induction of therapeutic hypothermia (32-34 degrees C) using the LRS ThermoSuit System. Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Neurothrombectomy will be performed if indicated.
干预措施: Propofol (Drug)
ThermoSuit Cooling Induction
Induction of therapeutic hypothermia (32-34 degrees C) using the LRS ThermoSuit System. Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Neurothrombectomy will be performed if indicated.
干预措施: Etomidate (Drug)
ThermoSuit Cooling Induction
Induction of therapeutic hypothermia (32-34 degrees C) using the LRS ThermoSuit System. Prior to initiating hypothermia, Magnesium Sulfate will be administered intravenously to control shivering and tPA administered intravenously (if indicated). Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort. Neurothrombectomy will be performed if indicated.
干预措施: Neurothrombectomy (Procedure)
结局指标
主要结局
Feasibility of cooling as indicated by percentage of patients cooled to target within 1 hour of start of cooling
时间窗: 1 hour after start of cooling
Feasibility of rapidly cooling victims of ischemic stroke with the ThermoSuit System to 32-34°C.
Change in neurological status as indicated by MRS
时间窗: Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke
Change in dichotomized modified Rankin scale from that measured at hospital discharge or 5-7 days post-treatment (whichever comes first) to that measured at 90 +/- 10 days post-stroke
Safety of the cooling treatment as indicated by rates of significant adverse events
时间窗: 30 days
A comparison of significant adverse event rates between the treatment and historical control group.
Neurological outcome as indicated by NIHSS
时间窗: Hospital discharge or day 5-7 post-treatment (whichever comes first)
NIH Stroke Scale at hospital discharge or day 5-7 post-treatment (whichever comes first)
Change in neurological outcome as indicated by NIHSS
时间窗: Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post-stroke
Change in NIHSS from that measured at hospital discharge or 5-7 days post-treatment (whichever comes first) to that measured at 90 +/- 10 days post-stroke
Neurological outcome as indicated by MRS score
时间窗: Hospital discharge or day 5-7 post-treatment (whichever comes first)
Dichotomized modified Rankin score (mRS); an mRS score of less than or equal to 2 is to be considered a good outcome
次要结局
- Mortality(90 days)
- Quality of Life as indicated by Neuro-QOL score(Hospital discharge or 5-7 days post-treatment (whichever comes first) and 90 +/- 10 days post stroke)
- Rates of procedure and device related SAEs(0 to 90 days)