NCT07415655 Modulation of Cerebral Ischemia by Albumin
| NCT ID | NCT07415655 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital Hradec Kralove |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2026-02-03 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07415655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07415655 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07415655 currently recruiting?
Yes, NCT07415655 is actively recruiting participants. Contact the research team at david.astapenko@fnhk.cz for enrollment information.
Where is the NCT07415655 trial being conducted?
This trial is being conducted at Hradec Králové, Czechia.
Who is sponsoring the NCT07415655 clinical trial?
NCT07415655 is sponsored by University Hospital Hradec Kralove. The trial plans to enroll 100 participants.
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