Clinical trial NCT06172387: Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for
Official title: The Efficacy of Intra-arterial Albumin With Endovascular Treatment for Acute Ischemic Stroke : A Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
albumin
intra-arterial
thrombectomy
neuroprotection
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: cerebral infarct volume
timeFrame: 24-48 hours after randomization
Secondary outcomes:
measure: modified Rankin Scale score(mRS)
timeFrame: 90 ±10 days after randomization
measure: the good prognosis at 90 days assessed by mRS
timeFrame: 90 ±10 days after randomization
measure: scores assessed by National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 ± 6 hours, 48 ± 12 hours, 7 ± 2 days, 90 ±10 days after randomization
measure: change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours
timeFrame: from baseline to 24 ± 6 hours
measure: improvement of neurologic function after 24 hours
timeFrame: 24 ± 6 hours after randomization
measure: Barthel index (BI)
timeFrame: 90 ±10 days after randomization
measure: revascularization on follow-up imaging
timeFrame: 24 (16 to 36) hours
measure: 24-hours neurologic deterioration
timeFrame: 24 ± 6 hours after randomization
measure: any intracranial hemorrhage on follow-up imaging
timeFrame: 24 (12 to 36) hours
measure: symptomatic intracerebral hemorrhage
timeFrame: 24 (12 to 36) hours
measure: Mortality
timeFrame: 90 ± 10 days after randomization
measure: Stroke recurrence
timeFrame: 90 ± 10 days after randomization
measure: Survival rates
timeFrame: 7 ± 2 days, 90 ± 10 days after randomization
measure: mRS4-6
timeFrame: 90 ± 10 days after randomization
Other outcomes:
Locations:
city: Tianjin, China
country: China
facility: Ming wei
state: Tianjin
Study officials:
References: