Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

Stroke, Acute Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953623
• Other study ID #: TJHH-2023-WeiMing617
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: July 2023
• Source: Tianjin Huanhu Hospital
• Contact: Ming wei, PhD
• Phone: 13502182903
• Email: drweiming[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Endovascular Procedures
• Ischemic Stroke
• Large Vessel Occlusion
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Huanhu Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Huanhu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.