Ischemic StrokePhase 2MOZEGNCT07415655
Modulation of Cerebral Ischemia by Albumin
A Phase 2 study testing Albumin infusion in people with Ischemic Stroke, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Albumin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Feb 2026to 1 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic stroke in the anterior circulation with or without thrombolysis administration
- vasographic intervention indication
Who cannot join
- pregnancy, breastfeeding
- known albumin hypersensitivity
- hypervolemia, hyperhydration
- hypernatremia
- another study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, Czech Republic, 50005
David Astapenko, MD, +420495833218, astad7ar@gmail.com
About this study
Official title: 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.
Read more
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
- Being tested
- Albumin infusion, Placebo Injection
- Keywords
- endothelial glycocalyx, ischemic stroke, albumin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin infusionDrug
Also called Albumin
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.
Placebo InjectionDrug
Also called Normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Albumin group | Experimental | Not described Receives: Drug: Albumin infusion |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syndecan-1 serum concentration
Assessment of syndecan-1 in the serum by the ELISA method. Results are a concentration in ng/ml.
Measured: 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.
Measured: Baseline, in 12 hours, 24 hours, 48 hours and 72 hours.
Secondary outcomes (2)
The brain ischemia volume
Assessment of the ischemia of the brain after a vasographic intervention on the follow-up CT scan calculated using a three-dimensional equation.
Measured: In 12 to 24 hours.
Neurological outcome
Neurological outcome assessed by the modified Rankin scale (7-level scale.
Measured: 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415655
- Sponsor's protocol ID
- 2023-509261-20-00
- Other IDs
- 2023
- Acronym
- MOZEG
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Extent of Ischemic Brain Damage by Protecting the Endothelial Glycocalyx With Low-Dose Albumin Administration
- ClinicalTrials.gov ID
- NCT07415655
- Acronym / sponsor ID
- MOZEG / 2023-509261-20-00
- Conditions
- Ischemic Stroke
- Keywords
- endothelial glycocalyx, ischemic stroke, albumin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin group | Experimental | Drug: Albumin infusion |
| Placebo | Placebo comparator | Drug: Placebo Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ischemic stroke in the anterior circulation with or without thrombolysis administration
- vasographic intervention indication
Key exclusion criteria (5 listed)
- pregnancy, breastfeeding
- known albumin hypersensitivity
- hypervolemia, hyperhydration
- hypernatremia
- another study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin infusionAlso: AlbuminAlbumin 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. | Drug | Albumin group |
| Placebo InjectionAlso: Normal salineNormal 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. | Drug | Placebo |
Primary outcome
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.
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.
2 secondary outcomes
The brain ischemia volume
Time frame: In 12 to 24 hours.
Neurological outcome
Time frame: 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin infusion in people with Ischemic Stroke, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Astapenko, M.D., Ph.D., MBA (+420495833218, david.astapenko@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syndecan-1 serum concentration (time frame: Baseline, in 12 hours, 24 hours, 48 hours and 72 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.