NCT05953623CompletedPhase 1
Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients
A Phase Ib Dose-Escalation Study of Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients
Source: ClinicalTrials.gov · Last updated 22 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 12 Jul 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 29 Jun 2024
- Lead sponsor
- Tianjin Huanhu Hospital
- Diseases
- Stroke
- NCT number
- NCT05953623
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 57
- From 1 Aug 2023 to the primary completion date, 29 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Computed tomography findings upon admission indicating the presence of any form of hemorrhage;
- Presence of other potentially life-threatening medical conditions;
Lab values
- Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
- Previous history of allergic reactions to albumin administration;
- Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin administration;
- 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.
Other
- Severe anemia characterized by a hematocrit below 32%;
- Pregnancy status;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Huanhu Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.