Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for

NCT ID: NCT06172387

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-31

Brief Summary

Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.

Detailed Description

In the previous period, we have conducted a clinical trial on the safety and feasibility of arterial infusion of 20% human serum albumin solution. The results of the study found that after arterial infusion of 20% human serum albumin solution at a dose of 0.6g/kg to the subject's vascularization area, the subjects did not develop significant complications related to albumin solution. There were no serious adverse events associated with arterial infusion of albumin solution in all subjects. After the evaluation of the Data Safety Monitoring Board, the clinical study was considered to be the next step, which is to initially explore the effectiveness of 0.6g/kg arterial infusion of 20% human serum albumin solution for neuroprotection of subjects.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; albumin; intra-arterial; thrombectomy; neuroprotection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intra-arterial group

20% human serum albumin (0.6g/kg) solution will be injected into the artery after revascularization in acute ischemic stroke. All participants will receive mechanical thrombectomy and a standard clinical therapy.

Group Type: EXPERIMENTAL

intra-arterial infusion albumin

Intervention Type: DRUG

The experimental group would inject 20% human blood albumin solution into the responsible blood vessel supply area by catheter artery at a dose of 0.6g/kg. The infusion time is 20-30 minutes. All participant will receive mechanical thrombectomy and a standard clinical therapy.

mechanical thrombectomy and a standard clinical therapy

Intervention Type: OTHER

mechanical thrombectomy and a standard clinical therapy

sham group

All participants have no intra-arterial albumin.

Group Type: OTHER

mechanical thrombectomy and a standard clinical therapy

Intervention Type: OTHER

mechanical thrombectomy and a standard clinical therapy

Interventions

intra-arterial infusion albumin

The experimental group would inject 20% human blood albumin solution into the responsible blood vessel supply area by catheter artery at a dose of 0.6g/kg. The infusion time is 20-30 minutes. All participant will receive mechanical thrombectomy and a standard clinical therapy.

Intervention Type: DRUG

mechanical thrombectomy and a standard clinical therapy

mechanical thrombectomy and a standard clinical therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1.Male or female, age≥18 and ≤ 80; 2. anterior circulation large vessel occlusion confirmed by CTA, MRA and DSA; 3. baseline National Institute of Health Stroke Scale (NIHSS) score ≥6； 4. Alberta Stroke Program Early CT Score (ASPECTS) 6-10; 5. Stroke symptoms present to femoral artery or brachial artery puncture within 24 hours； 6. occluded vessel reaches eTICI level ≥2b after thrombectomy confirmed by DSA；7. Informed consent obtained;

Exclusion Criteria

(1) history of congestive heart failure or jugular dilatation, third heart sound, resting tachycardia due to heart failure (>100 beats/min), hepatomegaly and lower limb edema without obvious cause on admission physical examination; (2) hospitalization for acute myocardial infarction within 3 months; (3) symptoms of acute myocardial infarction or admission electrocardiogram; (4) second or third degree heart block or arrhythmia with hemodynamic instability; (5) acute or chronic renal failure (blood creatinine > 2.0 mg/dL); (6) severe anemia (hematocrit<32%); (7) symptoms or CT evidence of subarachnoid hemorrhage; (8) pregnancy; (9) allergy to albumin; (10) admission blood pressure higher than 185/110 mmHg; (11) any chronic lung disease, including chronic obstructive pulmonary disease, bronchiectasis, and other lung diseases that interfere with daily activities; (12) presence of other diseases that may endanger life.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Huanhu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming Wei

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ming wei

Tianjin, China, Tianjin Municipality, China

Countries

China

Other Identifiers

TJHH-2023-WM121

Identifier Type: -

Identifier Source: org_study_id