跳至主要内容
临床试验/NCT06113848
NCT06113848招募中3 期

Feasibility and Efficacy of Intra- Arterial TNK and Albumin as an Adjunct to Thrombectomy for Acute Stroke

Tianjin Huanhu Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年9月7日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Number of participants with major response

研究概览

简要总结

The purpose of this study is to investigate the feasibility and efficacy of intra-arterial TNK and albumin for patients with acute ischemic stroke after successful thrombectomy and whether there is a synergistic effect between TNK and albumin.

详细描述

Endovascular therapy is the first-line treatment for acute ischemic stroke with large vessel occlusion. However, many studies have shown that, even with successful recanalization, about half of patients do not achieve functional independence. This phenomenon is called futile recanalization, which is partly attributed to brain no-reflow (microcirculation reperfusion failure despite recanalization of the occluded large artery). The mechanisms of brain no-reflow phenomenon include inflammation, micro thrombosis, aggregation platelets and red blood cells, and pericyte contraction.

Albumin, the most copious plasma protein synthesized primarily in the liver, possesses various biochemical properties, including anti-inflammatory, inhibiting platelet aggregation and micro thrombosis formation, and increasing microvascular perfusion. All of these properties are directed toward the mechanisms of no-reflow production, so albumin may inhibit no-reflow to improve the prognosis of stroke patients. TNK is a new generation thrombolytic agent that inhibits thrombosis, improves microcirculatory perfusion, and may inhibit no-reflow. These functions of TNK are similar to those of albumin, and the two also can reduce infraction volume and cerebral edema, and improve of behavioral function. In this study, we plan to determine the feasibility and efficacy of intra-arterial TNK and albumin for stroke patients undergoing successful mechanical thrombectomy and whether there is a synergistic effect between TNK and albumin.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intra-Arterial TNK and Albumin

Active Comparator

干预措施: Intra-Arterial TNK and Albumin (Drug)

Intra-Arterial TNK

Active Comparator

干预措施: Intra-Arterial TNK (Drug)

Intra-Arterial Albumin

Active Comparator

干预措施: Intra-Arterial Albumin (Drug)

sham

Sham Comparator

干预措施: sham (Other)

结局指标

主要结局

Number of participants with major response

时间窗: 7 days after initiation of TNK or albumin intra-arterially

Major response is any of the following: 1. Any forms of intracranial hemorrhage; 2. Pulmonary edema; 3. Heart failure; 4. Skin itching, dyspnea and other allergic reactions; 5. Death of any causes.

次要结局

未报告次要终点

研究者

发起方
Tianjin Huanhu Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming Wei

Chief Physician

Tianjin Huanhu Hospital

研究点 (1)

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