Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients (NCT05953623) | Clinical Trial Compass
CompletedPhase 1
Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients
China57 participantsStarted 2023-08-01
Plain-language summary
The purpose of this study is to investigate the safety and feasibility of intra-arterial albumin infusion for patients with acute ischemic stroke after successful thrombectomy and to further explore the optimal dose of albumin through the implementation of a 3 + 3 dose-escalation design. At the maximum safe dose determined in the 3+3 dose-escalation phase, an additional 15 to 20 patients will be enrolled in the study, and comparisons were made with external patients who received endovascular treatment alone.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Age 18 to 80 years;
* Patients with acute ischemic stroke caused by large vessel occlusion in the intracranial anterior circulation (internal carotid artery, middle cerebral artery M1 and M2 segments) ;
* mTICI score ≥ 2b for the occlude vessel after mechanical thrombectomy;
* Baseline National Institutes of Health Stroke score (NIHSS) ≥ 6;
* Stroke onset to arterial puncture time within 24 hours.
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 adminis…
What they're measuring
1
All cause of death
Timeframe: 90 days after initiation of infusion of albumin intra-arterially.