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Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

Primary Purpose

Stroke, Acute Ischemic, Albumin, Endovascular Procedures

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Albumin
Sponsored by
Tianjin Huanhu Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute Ischemic focused on measuring Acute Ischemic Stroke, Albumin, Endovascular Therapy, Large Vessel Occlusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. . 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.

Sites / Locations

  • Tianjin Huanhu Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-arterial albumin infusion

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2023
Last Updated
July 12, 2023
Sponsor
Tianjin Huanhu Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05953623
Brief Title
Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients
Official Title
A Phase Ib Dose-Escalation Study of Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Huanhu Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute Ischemic, Albumin, Endovascular Procedures, Large Vessel Occlusion
Keywords
Acute Ischemic Stroke, Albumin, Endovascular Therapy, Large Vessel Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-arterial albumin infusion
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Albumin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with major response
Description
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.
Time Frame
7 days after initiation of infusion of albumin intra-arterially.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. . 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming wei, PhD
Phone
13502182903
Email
drweiming@163.com
Facility Information:
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming wei
Phone
13502182903
Email
drweiming@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

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