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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06172387
• Other study ID #: TJHH-2023-WM121
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Tianjin Huanhu Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Ming wei	Tianjin, China	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Huanhu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral infarct volume	infarct volume is evaluated mainly through brain MRI	24-48 hours after randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	revascularization on follow-up imaging	secondary imaging efficacy endpoint	24 (16 to 36) hours
Secondary	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
Secondary	any intracranial hemorrhage on follow-up imaging	imaging safety endpoints; per ECASSIII definition and per Heidelberg bleeding classification	24 (12 to 36) hours
Secondary	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
Secondary	Mortality	clinical safety endpoint	90 ± 10 days after randomization
Secondary	Stroke recurrence	clinical safety endpoint	90 ± 10 days after randomization
Secondary	Survival rates	secondary clinical efficacy endpoint	7 ± 2 days, 90 ± 10 days after randomization
Secondary	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