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

The Efficacy of Intra-arterial Albumin With Endovascular Treatment for Acute Ischemic Stroke : A Randomized, Controlled Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: intra-arterial infusion albumin; Other: mechanical thrombectomy and a standard clinical therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, China, Tianjin, China, 300222
      • Ming wei

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other: mechanical thrombectomy and a standard clinical therapy; mechanical thrombectomy and a standard clinical therapy
Other: sham group; All participants have no intra-arterial albumin.	Other: mechanical thrombectomy and a standard clinical therapy; mechanical thrombectomy and a standard clinical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebral infarct volume	infarct volume is evaluated mainly through brain MRI	24-48 hours after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS4-6	secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)	90 ± 10 days after randomization
modified Rankin Scale score(mRS)	the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)	90 ±10 days after randomization
the good prognosis at 90 days assessed by mRS	the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)	90 ±10 days after randomization
scores assessed by National Institutes of Health Stroke Scale (NIHSS)	the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits	24 ± 6 hours, 48 ± 12 hours, 7 ± 2 days, 90 ±10 days after randomization
change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours	the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits	from baseline to 24 ± 6 hours
improvement of neurologic function after 24 hours	NIHSS score decreased by more than 4 points or NIHSS score was 0; secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severs deficits)	24 ± 6 hours after randomization
Barthel index (BI)	the BI is an ordinal disability score of 10 categories (range from 0-100, higher values indicate better prognosis)	90 ±10 days after randomization
revascularization on follow-up imaging	secondary imaging efficacy endpoint	24 (16 to 36) hours
24-hours neurologic deterioration	NIHSS score increased by more than 4 points; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits); clinical safety endpoint	24 ± 6 hours after randomization
any intracranial hemorrhage on follow-up imaging	imaging safety endpoints; per ECASSIII definition and per Heidelberg bleeding classification	24 (12 to 36) hours
symptomatic intracerebral hemorrhage	imaging safety endpoints; deterioration in NIHSS score of ≥4 point within 24 hours;per ECASS III definition and per Heidelberg bleeding classification	24 (12 to 36) hours
Mortality	clinical safety endpoint	90 ± 10 days after randomization
Stroke recurrence	clinical safety endpoint	90 ± 10 days after randomization
Survival rates	secondary clinical efficacy endpoint	7 ± 2 days, 90 ± 10 days after randomization

Collaborators and Investigators

• Sponsor: Tianjin Huanhu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: albumin; acute ischemic stroke; neuroprotection; thrombectomy; intra-arterial
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: TJHH-2023-WM121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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