Low‑dose albumin to reduce brain damage in anterior‑circulation ischemic stroke
Modulation of the Extent of Ischemic Brain Damage by Protecting the Endothelial Glycocalyx With Low-Dose Albumin Administration
This trial tests whether giving low‑dose albumin around the time of vasographic intervention helps adults with anterior‑circulation ischemic stroke recover better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Hradec Kralove Academic / other |
| Locations | 1 site (Hradec Králové, Czech Republic) |
| Trial ID | NCT07415655 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, open‑label, placebo‑controlled phase II trial enrolls patients with anterior‑circulation ischemic stroke who have an indication for vasographic intervention. Participants are randomized to receive a low‑dose albumin infusion or placebo at the time of the angiographic procedure. The timeline includes brief screening and randomization, administration during the intervention, and then ICU and ward follow-up with a primary visit at Day 90 (±7 days), for a maximum total participation of 97 days. The trial is designed to test whether albumin preserves the endothelial glycocalyx and reduces ischemic brain injury compared with placebo.
Who should consider this trial
Good fit: Adults with anterior‑circulation ischemic stroke who are candidates for vasographic (angiographic) intervention and who do not have pregnancy, albumin hypersensitivity, hypervolemia, or hypernatremia are the ideal candidates.
Not a fit: Patients without anterior‑circulation stroke or without an indication for vasographic intervention, pregnant or breastfeeding individuals, those with known albumin hypersensitivity, hypervolemia, hypernatremia, or current participation in another trial are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could reduce brain injury from the stroke and improve functional recovery at 90 days.
How similar studies have performed: Previous large trials of high‑dose albumin in acute stroke did not show clear benefit and raised safety concerns, so the low‑dose, glycocalyx‑focused approach in this trial remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hradec Králové, Czech Republic
- University Hospital Hradec Kralove — Hradec Králové, Czech Republic, Czechia (Recruiting)
Study contacts
- Study coordinator: David Astapenko, M.D., Ph.D., MBA
- Email: david.astapenko@fnhk.cz
- Phone: +420495833218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.