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

NCT06172387 | Unknown Phase 1 DMC

• 1 other identifier: TJHH-2023-WM121
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• cerebral infarct volume

  infarct volume is evaluated mainly through brain MRI

  24-48 hours after randomization

Secondary Outcomes (14)

• modified Rankin Scale score(mRS)

  90 ±10 days after randomization

• the good prognosis at 90 days assessed by mRS

  90 ±10 days after randomization

• scores assessed by National Institutes of Health Stroke Scale (NIHSS)

  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

  from baseline to 24 ± 6 hours

• improvement of neurologic function after 24 hours

  24 ± 6 hours after randomization

Study Arms (2)

intra-arterial group

EXPERIMENTAL

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; Other: mechanical thrombectomy and a standard clinical therapy

sham group

OTHER

All participants have no intra-arterial albumin.

Other: mechanical thrombectomy and a standard clinical therapy

Interventions

intra-arterial infusion albumin 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.

intra-arterial group

mechanical thrombectomy and a standard clinical therapy OTHER

mechanical thrombectomy and a standard clinical therapy

intra-arterial group; sham group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• (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.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Ming wei

Tianjin, China, Tianjin Municipality, 300222, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

CN (1)