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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Large Vessel Occlusion; Endovascular Procedures; Stroke, Acute Ischemic; Albumin
• Intervention / Treatment: Biological: Albumin

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ming Wei, PhD; Phone Number: 13502182903; Email: drweiming@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300222
      • Tianjin Huanhu Hospital
      • Contact: Ming Wei; Phone Number: 13502182903; Email: drweiming@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.

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Exclusion Criteria:

1. 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;
2. History of acute myocardial infarction within the preceding 3 months;
3. 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;
4. Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
5. Severe anemia characterized by a hematocrit below 32%;
6. Computed tomography findings upon admission indicating the presence of any form of hemorrhage;
7. Pregnancy status;
8. Previous history of allergic reactions to albumin administration;
9. Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin administration;
10. Presence of other potentially life-threatening medical conditions;
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with major response	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.	7 days after initiation of infusion of albumin intra-arterially.

Collaborators and Investigators

• Sponsor: Tianjin Huanhu Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Large Vessel Occlusion; Acute Ischemic Stroke; Albumin; Endovascular Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: TJHH-2023-WeiMing617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No