Thrombolysis in Minor Stroke - MINOR Study

AUSL di Piacenza0 个研究点目标入组 340 人开始时间: 2013年6月7日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•Acute ischemic stroke;
•age > 18 years and < 80 years;
•stroke symptom onset within 4.5 hours before administration of rt-PA;
•mild stroke with an NIHSS score <5 at admission (stable or improving deficits);
•written informed consent;
•unknown onset strokes, with perfusion/diffusion mismatch” demonstrated by brain perfusion-Computed Tomography o diffusion/perfusion enhanced Magnetic Resonance Imaging.
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•intracranial haemorrhage at the CT scan;
•pregnancy or woman of childbearing age who does not take contraceptives;
•space occupying mass at the brain CT scan;
•unknown time of onset;
•moderate or severe stroke with an NIHSS score of > 5;
•ASPECT CT brain score > 7;
•seizure at the onset of stroke with the inability to use PI-TC or RM PI-DWI. Seizures are not exclusion criteria if ischemia is demonstrated by techniques of mismatch.
•stroke or serious head trauma within the previous 3 months;
•the administration of heparin within 48 hours preceding the onset of the stroke, with an activated partial-thromboplastin time at presentation exceeding the upper limit for the normal range;
•platelet count of less than 100,000/mmc;
•a systolic pressure higher than 185 mmHg or diastolic pressure higher than 110 mmHg that cannot be corrected with appropriate therapy
•blood glucose level lesser than 50 mg per deciliter or greater than 400 mg per deciliter;
•symptoms suggestive of subarachnoid haemorrhage, even in the presence of a normal CT brain scan;
•oral anticoagulant treatment and an INR score > 1.4;
•major surgery or severe trauma within the previous 3 months;
•other major disorders known to be associated with an increased risk of bleeding.

发起方

AUSL di Piacenza