Modulation of Cerebral Ischemia by Albumin

NCT07415655 | Recruiting Phase 2

• 1 other identifier: 2023-509261-20-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, open-label, randomized, placebo-controlled, prospective phase II clinical trial to investigate the efficacy of low-dose albumin in patients with ischemic stroke with an indication for vasographic intervention. The clinical trial consists of the following phases: Screening, randomization, treatment phase - administration of albumin/placebo and vasographic intervention (with the duration of all these 3 phases in the order of hours) and a follow-up phase, which takes place first in the intensive care unit (ICU) and then in a standard ward and lasts 90 (±7) days. The clinical trial ends with the End of Study/Day 90 visit. The total maximum duration of patient participation in the clinical trial is therefore 97 days, including Follow-up. Ischemic stroke is caused by local perfusion impairment due to thromboembolism or thrombosis at the site of perfusion impairment. The damaged brain area is projected into the patient's neurological clinical picture. The primary stroke cannot be influenced by therapeutic procedures, however, the area of the so-called penumbra (the surroundings of the ischemic lesion, where vasoreactivity is impaired and the blood-brain barrier is more or less damaged) can be, which is the main goal of therapy, as well as improving the neurological clinical outcome of patients as much as possible (thrombolysis, neuroangiointervention). Research over the past 20 years has highlighted the importance of the endothelial glycocalyx (EG) and has proposed a number of concepts and substances with a protective and reparative effect. Albumin has come to the forefront of interest. The study assumes a benefit for patients in the form of non-circulatory effects of administered albumin: improvement of EG condition in the penumbra area of the ischemic focus, improvement of microrheology, and antioxidant protection. Albumin therapy has been used for 80 years and is generally well tolerated. Allergy to albumin is rare, as it is a protein of the body's own from healthy donors. The concomitantly used medicinal products are highly purified. The selected dosage should not endanger the patient in any way in terms of circulatory overload, pulmonary edema, and, we assume, also in terms of bleeding into the ischemic focus of the brain. Study drug: albumin. Any albumin available on the market in the dose and strength specified in the protocol can be used. The reference SmPC is Alburex (manufacturer CSL Behring). Placebo: Fresenius Kabi 0.9% saline solution. It is planned to enroll 100 patients.

Conditions

Ischemic Stroke

Keywords

endothelial glycocalyx; ischemic stroke; albumin

Outcome Measures

Primary Outcomes (2)

• Syndecan-1 serum concentration

  Assessment of syndecan-1 in the serum by the ELISA method. Results are a concentration in ng/ml.

  Baseline, in 12 hours, 24 hours, 48 hours and 72 hours.

• Glycoyaminoglycans in the urine concentration

  The concentration of all the glycosaminoglycans excreted into the urine. The assessment by spectrophotometry. Concentration in mg/ml.

  Baseline, in 12 hours, 24 hours, 48 hours and 72 hours.

Secondary Outcomes (2)

• The brain ischemia volume

  In 12 to 24 hours.

• Neurological outcome

  90 days.

Study Arms (2)

Albumin group

EXPERIMENTAL

Drug: Albumin infusion

Placebo

PLACEBO COMPARATOR

Drug: Placebo Injection

Interventions

Albumin infusion DRUG

Albumin will be given to the eligible patients during the vasographic intervention intravenously within 20 minutes. The dose is unified for all participants - 100 ml of 20 % human serum albumin.

Also known as: Albumin

Albumin group

Placebo Injection DRUG

Normal saline as a placebo will be given to the eligible patients during the vasographic intervention intravenously within 20 minutes. The dose is unified for all participants: 100 ml of 0,9 % sodium chloride.

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ischemic stroke in the anterior circulation with or without thrombolysis administration
• vasographic intervention indication

You may not qualify if:

• pregnancy, breastfeeding
• known albumin hypersensitivity
• hypervolemia, hyperhydration
• hypernatremia
• another study participation

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, Czech Republic, 50005, Czechia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Albumins; Saline Solution

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

David Astapenko, M.D., Ph.D., MBA

CONTACT

+420495833218; david.astapenko@fnhk.cz

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 17, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-01

Locations

CZ (1)