Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTingyu-Yi

About this trial

This project intends to explore the therapeutic efficacy of human serum albumin in mitigating postoperative cerebral edema and enhancing clinical outcomes following mechanical thrombectomy in patients with acute anterior circulation large-core ischemic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old.

Acute ischemic stroke patients with NIHSS score ≥ 6.

Pre-stroke mRS (modified Rankin Scale) score ≤ 1.

Onset of symptoms to presentation within 24 hours, including wake-up strokes or strokes without witnessed onset; the time of symptom onset is defined as the "last seen normal" time.

Disqualifiers

Intracranial hemorrhage confirmed by head CT or MRI.

Pre-stroke mRS score > 2.

Severe allergy or absolute contraindication to iodine-based contrast agents.

Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and inability to control with antihypertensive medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patients with AIS receive intravascular therapy, and within 10 minutes after the surgery, they are administered 100ml of 20% human albumin intravenously (infused within 30 minutes).

    Drug

    Whether to administer albumin to AIS patients after intravascular thrombectomy and reperfusion.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Albumin groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Functional independence Rate

mRS score of 0-2

Time frame
From enrollment to the end of treatment at 3 months

Secondary outcomes

1

Rate of independent ambulation

modified Rankin Scale score of 0-3 scores

Time frame
From enrollment to the end of treatment at 3 months

Other outcomes

1

sICH occurrence

New occurs Intracranial hemorrhage with NIHSS increase \>=4 points

Time frame
within 72 hours after enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tingyu-Yi

Lead sponsor

Zhangzhou Municipal Hospital

Sponsor institution