Basilar Artery International Cooperation Study Trial - BASICS Trial

BASICS Study Group0 个研究点目标入组 750 人开始时间: 2010年11月16日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•Symptoms and signs compatiblewith ischemia in the basilar artery territory
•Basilar artery occlusion confirmed by CTA or MRA
•Age18 or older (i.e., candidates must have had their 18th birthday).
•If IVT is considered as part of best medical treatment IV rt-PA needs to be initiated within 4.5 hours of estimated time of basilar artery occlusion. (Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms – this time is not necessarily the same as the time of onset of first symptoms).
•Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.
•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 375
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 375

•Pre-existing dependency with mRankin =3.
•Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
•Patients that require hemodialysis or peritoneal dialysis.
•Other serious, advanced, or terminal illness.
•Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated.
•Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
•Informed consent is not or can not be obtained.
•Imaging Exclusion Criteria:
•Lesion consistent with hemorrhage of any degree.
•Significant cerebellar mass effect or acute hydrocephalus
•Bilateral extended brainstem ischemia.

发起方

BASICS Study Group