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Clinical Trials/NCT06113848
NCT06113848
Recruiting
Phase 3

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

Tianjin Huanhu Hospital1 site in 1 country80 target enrollmentSeptember 7, 2023

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2023
End Date
September 7, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tianjin Huanhu Hospital
Responsible Party
Principal Investigator
Principal Investigator

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.

Study Sites (1)

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