NCT06113848

Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Intra-Arterial TNK and Albumin	The study population was divided into four groups, one of which had intra-arterial TNK and albumin.
DRUG	Intra-Arterial TNK	The study population was divided into four groups, one of which had intra-arterial TNK .
DRUG	Intra-Arterial Albumin	The study population was divided into four groups, one of which had intra-arterial albumin.
OTHER	sham	The study population was divided into four groups, one of which had no intra-arterial TNK and albumin.

Timeline

• Start date: 2023-09-07
• Primary completion: 2024-09-07
• Completion: 2024-09-07
• First posted: 2023-11-02
• Last updated: 2023-11-02

Locations

1 site across 1 country: China