Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy

• Status: Recruiting
• Trial end date: 2024-09-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Huanhu Hospital

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.