Randomised Trial of Contrast-enhanced Sonothrombolysis in acute ischaemic stroke - NOR-SASS

Helse Bergen, Haukeland University Hospital0 个研究点开始时间: 2012年4月2日最近更新: 2014年3月24日

研究概览

暂无简介。

•Inclusion criteria
•Patients 18 years or older with acute ischaemic stroke
•Treatment must be delivered within 4½ hours of symptom onset
•Patients who fulfil NOR-TEST criteria for iv thrombolysis are eligible for the CEST arm
•Patients who have a contraindication for thrombolysis are eligible for the CES arm
•Informed written consent signed by the patient, verbal consent from the patient as witnessed by a non-participating health care person, or consent by the signature of the patient's family must be provided before treatment. Patients for whom no informed consent can be obtained will not be included in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•Exclusion criteria
•Patients with premorbid modified Rankin Scale (mRS) score =3;
•· Patients for whom a complete NIH Stroke Score cannot be obtained;
•· Hemiplegic migraine with no arterial occlusion on baseline CT;
•· Seizure at stroke onset and no visible occlusion on baseline CT;
•· Intracranial haemorrhage on baseline CT;
•· Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal;
•· Large areas of hypodense ischaemic changes on baseline CT;
•· Patients with primary endovascular treatment;
•· Female, pregnant or breast feeding; pericarditis; sepsis; any other serious medical illness likely to
•interact with treatment; confounding pre-existent neurological or psychiatric disease; unlikely to
•complete follow-up; any investigational drug <14 days;
•Specific sonothrombolysis exclusion criteria
•· known hypersensitivity/allergy to SonoVue;
•· recent or unstable coronary ischemia or resting angina <7 days;
•· acute cardiac insufficiency, cardiac insufficiency class III/IV; serious cardiac arrhythmias;
•· any right-left-shunt; severe pulmonary hypertension (PAP >90 mmHg); uncontrolled hypertension;
•· moderate to severe COPD (baseline O2 saturation <80%);
•· acute respiratory distress syndrome (ARDS);
•· no temporal bone window” for ultrasound examination.

发起方

Helse Bergen, Haukeland University Hospital