Feasibility and Efficacy of Intra- Arterial TNK and Albumin as an Adjunct to Thrombectomy for Acute Stroke
Overview
- Phase
- Phase 3
- Intervention
- Intra-Arterial TNK and Albumin
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Tianjin Huanhu Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of participants with major response
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ming Wei
Chief Physician
Tianjin Huanhu Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intra-Arterial TNK and Albumin
Intervention: Intra-Arterial TNK and Albumin
Intra-Arterial TNK
Intervention: Intra-Arterial TNK
Intra-Arterial Albumin
Intervention: Intra-Arterial Albumin
sham
Intervention: sham
Outcomes
Primary Outcomes
Number of participants with major response
Time Frame: 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.