Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy

NCT ID: NCT06113848

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-07
• Study Completion Date: 2024-09-07

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-Arterial TNK and Albumin

Group Type: ACTIVE_COMPARATOR

Intra-Arterial TNK and Albumin

Intervention Type: DRUG

The study population was divided into four groups, one of which had intra-arterial TNK and albumin.

Intra-Arterial TNK

Group Type: ACTIVE_COMPARATOR

Intra-Arterial TNK

Intervention Type: DRUG

The study population was divided into four groups, one of which had intra-arterial TNK .

Intra-Arterial Albumin

Group Type: ACTIVE_COMPARATOR

Intra-Arterial Albumin

Intervention Type: DRUG

The study population was divided into four groups, one of which had intra-arterial albumin.

sham

Group Type: SHAM_COMPARATOR

sham

Intervention Type: OTHER

The study population was divided into four groups, one of which had no intra-arterial TNK and albumin.

Interventions

Intra-Arterial TNK and Albumin

The study population was divided into four groups, one of which had intra-arterial TNK and albumin.

Intervention Type: DRUG

Intra-Arterial TNK

The study population was divided into four groups, one of which had intra-arterial TNK .

Intervention Type: DRUG

Intra-Arterial Albumin

The study population was divided into four groups, one of which had intra-arterial albumin.

Intervention Type: DRUG

sham

The study population was divided into four groups, one of which had no intra-arterial TNK and albumin.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. AIS patients with large vessel occlusion;

2. Age between 18 and 80 years;

3. Baseline NIHSS score ≥ 6; 4 .Successful recanalization after thrombectomy (mTICI grades ≥ 2b);

5. ASPECTS score ≥ 6 on CT; 6. First episode or previous episode without significant sequelae (mRS ≤ 2); 7. Time from onset to femoral artery puncture ≤ 24 hours; 8. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria

1. Upon admission, the patient's medical history and physical examination revealed manifestations indicative of congestive heart failure (CHF), such as jugular venous distention, the presence of a third heart sound, resting tachycardia at a rate of 100 beats per minute attributable to heart failure, hepatomegaly, and/or lower extremity edema attributable to heart failure or of unknown etiology;

2. History of acute myocardial infarction within the preceding 3 months;

3. The patient's medical history, electrocardiogram findings upon admission, or physical examination indicated the presence of second- or third-degree heart block or any arrhythmia associated with hemodynamic instability, as determined by the investigator's assessment;

4. Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;

5. Severe anemia characterized by a hematocrit below 32%;

6. Computed tomography findings upon admission indicating the presence of any form of hemorrhage;

7. Pregnancy status;

8. Previous history of allergic reactions to albumin administration or TNK administration;

9. Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin administration or TNK administration;

10. Presence of other potentially life-threatening medical conditions;

11. Individuals with current chronic lung diseases, such as chronic obstructive pulmonary disease, bronchiectasis, or any other lung disorder that significantly impairs daily activities;

12. Individuals with known allergies to albumin or TNK;

13. Patients with reocclusion within 24 hours;

14. Clinical suspicion of aortic coarctation、 bacterial embolism and infective endocarditis;

15. Patients with a history of coagulation disorders and systemic bleeding tendencies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Huanhu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming Wei

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ming Wei, PhD

Role: primary

drweiming@163.com

13502182903

Other Identifiers

TJHH-2023-wm16

Identifier Type: -

Identifier Source: org_study_id