Last updated: October 27, 2023
Sponsor: Tianjin Huanhu Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Blood Clots
Cerebral Ischemia
Stroke
Treatment
sham
Intra-Arterial TNK
Intra-Arterial TNK and Albumin
Clinical Study ID
NCT06113848
TJHH-2023-wm16
Ages 18-80 All Genders
Study Summary
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 (mTICIgrades ≥ 2b);
- ASPECTS score ≥ 6 on CT; 6. First episode or previous episode without significantsequelae (mRS ≤ 2); 7. Time from onset to femoral artery puncture ≤ 24 hours; 8. Writteninformed consent provided by the patients or their legal relatives.
Exclusion
Exclusion criteria:
- Upon admission, the patient's medical history and physical examination revealedmanifestations indicative of congestive heart failure (CHF), such as jugular venousdistention, the presence of a third heart sound, resting tachycardia at a rate of 100beats per minute attributable to heart failure, hepatomegaly, and/or lower extremityedema 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 physicalexamination indicated the presence of second- or third-degree heart block or anyarrhythmia associated with hemodynamic instability, as determined by theinvestigator'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 ofhemorrhage;
- Pregnancy status;
- Previous history of allergic reactions to albumin administration or TNKadministration;
- Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albuminadministration or TNK administration;
- Presence of other potentially life-threatening medical conditions;
- Individuals with current chronic lung diseases, such as chronic obstructive pulmonarydisease, bronchiectasis, or any other lung disorder that significantly impairs dailyactivities;
- Individuals with known allergies to albumin or TNK;
- Patients with reocclusion within 24 hours;
- Clinical suspicion of aortic coarctation、 bacterial embolism and infectiveendocarditis;
- Patients with a history of coagulation disorders and systemic bleeding tendencies.
Study Design
Total Participants: 80
Treatment Group(s): 4
Primary Treatment: sham
Phase: 3
Study Start date:
September 07, 2023
Estimated Completion Date:
September 07, 2024
Study Description
Connect with a study center
Tianjin Huanhu Hospital
Tianjin, Tianjin 300222
ChinaActive - Recruiting
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