Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

Sponsor

Tianjin Huanhu Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05953623

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Ischemic Albumin Endovascular Procedures Large Vessel Occlusion	Biological: Albumin	Phase 1

Detailed Description

Albumin, the predominant plasma protein synthesized primarily in the liver, possesses various biochemical properties that are expected to confer a neuroprotective effect following acute ischemic stroke. Despite being utilized as a neuroprotective agent for stroke patients, albumin has not demonstrated efficacy, partly due to the persistence of the occluded vessel responsible for the stroke, thereby hindering the albumin's ability to exert its therapeutic effects in the ischemic region. In light of the advent of thrombectomy and subsequent recanalization of occluded blood vessels, it is imperative to reassess the potential impact of albumin. In this study, we plan to conduct a 3 + 3 dose-escalation trial to determine the safety and feasibility of intra-arterial albumin infusion for stroke patients undergoing successful mechanical thrombectomy. Since this is a 3 + 3 dose-escalation study with 5 doses (0.25g/kg, 0.35g/kg, 0.40g/kg, 0.45g/kg, 0.5g/kg), a minimum of 15 (5 groups × 3 patient/group) patients will be required, assuming no major response occurs at any dose level, and a maximum of 30 (5 groups × 6 patient/group) patients will be required, assuming one major response occurs at each dose level. The present study is expected to provide the basis for subsequent phase 2 randomized control trials to explore the efficacy of intra-arterial albumin infusion.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase Ib Dose-Escalation Study of Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra-arterial albumin infusion	Biological: Albumin This is a 3 + 3 dose-escalation study with 5 doses (0.25g/kg, 0.35g/kg, 0.40g/kg, 0.45g/kg, 0.5g/kg). Intra-arterial albumin infusion will be applied after successful recanalization of the culprit artery in the anterior circulation.

Arm

Intervention/Treatment

Experimental: Intra-arterial albumin infusion

Biological: Albumin

This is a 3 + 3 dose-escalation study with 5 doses (0.25g/kg, 0.35g/kg, 0.40g/kg, 0.45g/kg, 0.5g/kg). Intra-arterial albumin infusion will be applied after successful recanalization of the culprit artery in the anterior circulation.

Outcome Measures

Primary Outcome Measures

Number of participants with major response [7 days after initiation of infusion of albumin intra-arterially.]
Major response is any of the following: Any forms of Intracranial hemorrhage; Pulmonary edema; Heart failure; Skin itching, dyspnea and other allergic symptoms; Death of any causes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

AIS patients with anterior circulation due to large vessel occlusion; 2. Age between 18 and 80 years; 3. Baseline NIHSS score ≥ 6; 4 .Successful recanalization after thrombectomy (mTICI grade ≥ 2b); 5. 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;
Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin 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; 12. Individuals with known allergies to albumin.