Status:
UNKNOWN
Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy
Lead Sponsor:
Tianjin Huanhu Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
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 patien...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- AIS patients with large vessel occlusion;
- Age between 18 and 80 years;
- 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:
- 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;
- History of acute myocardial infarction within the preceding 3 months;
- 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;
- Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
- Severe anemia characterized by a hematocrit below 32%;
- Computed tomography findings upon admission indicating the presence of any form of hemorrhage;
- Pregnancy status;
- Previous history of allergic reactions to albumin administration or TNK administration;
- Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin administration or TNK administration;
- Presence of other potentially life-threatening medical conditions;
- Individuals with current chronic lung diseases, such as chronic obstructive pulmonary disease, bronchiectasis, or any other lung disorder that significantly impairs daily activities;
- Individuals with known allergies to albumin or TNK;
- Patients with reocclusion within 24 hours;
- Clinical suspicion of aortic coarctation、 bacterial embolism and infective endocarditis;
- Patients with a history of coagulation disorders and systemic bleeding tendencies.
Exclusion
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 7 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06113848
Start Date
September 7 2023
End Date
September 7 2024
Last Update
November 2 2023
Active Locations (1)
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1
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China, 300222