A Multicentre, Randomised, Placebo contolled trial of intravenous 10% Dextran 40 (Rheomacrodex), in the Prevention of Stroke in Carotid Surgery

ational Stroke Research Institute and John Hunter Health0 个研究点目标入组 1,412 人开始时间: 2009年8月6日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Symptomatic or a symptomatic carotid artery atherosclerosis considered suitable for Carotid Endarterectomy (CEA) performed under either general or loco-regional anaesthesia.

•Documented history of congestive cardiac failure New York Heart Association Functional Classification equal to or greater than 3 (NYHA=/>GD 3), unstable angina or acute myocardial infarction within 3 months of surgery.
•Renal impairment as measured by a serum creatinine of greater than 0.20 mmol/l.
•Thrombocytopaenia of less than 100,000/mm3.
•Previous hypersensitivity to dextrans.
•Concomitant ipsilateral balloon and/or stenting procedure with CEA.
•Patients remaining on warfarin during surgery and those who will receive concomitant heparin therapy post-operatively are also excluded. Patients who are treated with warfarin (without heparin) may be included if the International Normalised Ratio (INR) on the day of surgery is below 1.5.
•Lack of informed consent.
•Combined CEA/Coronary Artery Bypass Grafts (CABGs) procedure.

发起方

ational Stroke Research Institute and John Hunter Health