Using TNK and Albumin after Thrombectomy for Stroke Patients

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

This study is testing if using a combination of TNK and albumin after a thrombectomy can help stroke patients improve blood flow to the brain and recover better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tianjin Huanhu Hospital (Academic / other)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06113848 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of intra-arterial TNK and albumin in patients who have undergone successful thrombectomy for acute ischemic stroke. It aims to address the issue of 'no-reflow,' where blood flow does not adequately return to the brain despite the removal of a blockage. By combining TNK, a thrombolytic agent, with albumin, which has anti-inflammatory properties, the study seeks to improve patient outcomes and reduce complications. The trial will assess the feasibility and potential synergistic effects of these treatments in enhancing microvascular perfusion and functional recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with acute ischemic stroke due to large vessel occlusion who have undergone successful thrombectomy.

Not a fit: Patients with congestive heart failure or recent myocardial infarction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and functional independence for stroke patients after thrombectomy.

How similar studies have performed: While the combination of TNK and albumin is a novel approach, previous studies have shown promise in addressing no-reflow phenomena in stroke treatment.

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.

Where this trial is running

Tianjin, Tianjin

• Tianjin Huanhu Hospital — Tianjin, Tianjin, China (Recruiting)

Conditions Acute Ischemic Stroke; Acute ischemic stroke; Albumin; TNK; No-reflow; Endovascular Therapy; Large Vessel Occlusion