Modulation of Cerebral Ischemia by Albumin (MOZEG)

April 30, 2026 updated by: University Hospital Hradec Kralove

Modulation of the Extent of Ischemic Brain Damage by Protecting the Endothelial Glycocalyx With Low-Dose Albumin Administration

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Czech Republic
      • Hradec Králové, Czech Republic, Czechia, 50005
        • Recruiting
        • University hospital Hradec Králové
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo Injection
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.
Other Names:
  • Normal saline
Experimental: Albumin group
Drug: Albumin infusion
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.
Other Names:
  • Albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syndecan-1 serum concentration
Time Frame: Baseline, in 12 hours, 24 hours, 48 hours and 72 hours.
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
Time Frame: Baseline, in 12 hours, 24 hours, 48 hours and 72 hours.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The brain ischemia volume
Time Frame: In 12 to 24 hours.
Assessment of the ischemia of the brain after a vasographic intervention on the follow-up CT scan calculated using a three-dimensional equation.
In 12 to 24 hours.
Neurological outcome
Time Frame: 90 days.
Neurological outcome assessed by the modified Rankin scale (7-level scale.
90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-509261-20-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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