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临床试验/DRKS00031086
DRKS00031086招募中3 期

Combination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke (COTTIS-2) – a randomised controlled study - COTTIS-2

niversitätsklinikum Freiburg0 个研究点目标入组 400 人开始时间: 2024年2月19日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
入组人数
400

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • oPre-stroke modified Rankin Scale (mRS) 0-2
  • oAcute ischemic stroke with NIHSS >5
  • oIndication for endovascular treatment (thrombectomy)
  • oIntracranial occlusion of the M1 or M2 segment of the middle cerebral artery (MCA) or internal carotid artery (ICA) or tandem occlusion on CT-angiography or MR-angiography
  • oTime window:
  • -Last seen normal to groin puncture < 6h: native CT or MRI-DWI with Alberta Stroke Program Early CT score (ASPECTS) >5
  • -Last seen normal to groin puncture 6-24h or unknown time window: significant mismatch imaging according to the eligibility criteria of the DEFUSE-3 trial:
  • - Infarct core <70ml (DWI oder CBF<30% of contralateral site)
  • - Penumbra > 15ml (Tmax >6sec)
  • - Ratio penumbra/core >1.8
  • owith or without iv thrombolysis with rtPA

排除标准

  • oPatients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system.
  • oKnown severe hemorrhagic diathesis (International Normalized Ratio (INR) >3.0, partial thromboplastin time (PTT) > 70s, platelet count < 50.000/µl)
  • oBrain trauma or neurovascular surgery/intervention <3 months
  • oSevere infection
  • oPregnant women or women of childbearing potential (women of childbearing potential with negative pregnancy test may be included)
  • oKnown cerebral vasculitis
  • oProof of bleeding in cerebral CT or MRI (cerebral microbleeds in MRI [hypertensive or in the context of cerebral amyloid angiopathy] is permitted).
  • oLife expectancy < 6 months

研究者

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