Status:
UNKNOWN
Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for
Lead Sponsor:
Tianjin Huanhu Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 lead...
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 in...
Eligibility Criteria
Inclusion
- 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
- (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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06172387
Start Date
November 1 2023
End Date
December 1 2024
Last Update
December 15 2023
Active Locations (1)
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1
Ming wei
Tianjin, China, Tianjin Municipality, China, 300222