Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy

Phase 3

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Intra-Arterial TNK; Drug: Intra-Arterial Albumin; Other: sham; Drug: Intra-Arterial TNK and Albumin

• Registration Number: NCT06113848
• Lead Sponsor: Tianjin Huanhu Hospital

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.

Study Timeline

• Study Start: 2023-09-07
• Status Verified: 2023-10
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-09-07
• Study Completion: 2024-09-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-Arterial TNK	Intra-Arterial TNK	-
Intra-Arterial Albumin	Intra-Arterial Albumin	-
sham	sham	-
Intra-Arterial TNK and Albumin	Intra-Arterial TNK and Albumin	-

Primary Outcome Measures

Name	Time	Method
Number of participants with major response	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.

Trial Locations

Locations (1)

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China