Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCapital Medical University

About this trial

This study is a prospective, multicenter, open-label, randomized controlled clinical trial. The investigators will apply albumin to the reperfusion treatment of patients with acute ischemic stroke in the anterior circulation. This study aims to verify the efficacy and safety of albumin combined with endovascular treatment in patients with anterior circulation acute ischemic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years;

Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;

Anterior circulation acute ischemic stroke, with acute occlusion of the responsible vessel located in the intracranial segment of the internal carotid artery, or the M1 or M2 segment of the middle cerebral artery;

National Institute of Health Stroke Scale (NIHSS) score >=6;

Disqualifiers

Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan;

History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;

Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;

Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Albumin

    Drug

    25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered intravenously. On the second, third, and fourth days, 25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered daily.

  • Endovascular treatment

    Procedure/Surgery

    Best endovascular treatment.

Treatment groups

1,192 Participants
are divided into 2 treatment groups
Group A: Albumin combined with endovascular treatment groupExperimental treatment 2 interventions
Group B: Endovascular treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days.

Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)

Time frame
90 days

Secondary outcomes

1

Distribution of mRS scores

Time frame
90 days and 1 year
2

Proportion of patients with mRS score 0-1

Time frame
90 days and 1 year
3

24h National Institutes of Health Stroke Scale (NIHSS)

The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.

Time frame
24 hours
4

National Institutes of Health Stroke Scale (NIHSS) at 7 days

The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.

Time frame
7 days

Other outcomes

1

The incidence of symptomatic intracerebral hemorrhage

Time frame
7 days
2

The incidence of newly onset atrial fibrillation within 7 days

Time frame
7 days
3

The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days

Time frame
7 days
4

All-cause mortality rate

Time frame
90 days and 1 year

Sponsors and contacts

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