Modulation of the Extent of Ischemic Brain Damage by Protecting the Endothelial Glycocalyx with Low-Dose Albumin Administration (MOZEG)
Key facts
- Where
- Hradec Králové, CsehországSee the site
- Phase
- 2. fázis
Where in Csehország
- Fakultni nemocnice Hradec KraloveHradec Králové, CsehországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fakultni Nemocnice Hradec Kralove
- Trial code
- EU 2023-509261-20-00
- Record updated
- 2025. március 26.
- Original description
Evaluation of the efficacy of albumin as a protection for the glycocalyx and endothelial functions.Read full original descriptionShow less
Evaluation of the efficacy of albumin as a protection for the glycocalyx and endothelial functions.
Inclusion: Age ≥ 18 years; Provision of consent to participate in the clinical study by the patient or an independent physician, depending on the patient’s medical condition; Diagnosis of ischemic stroke (iCMP) in the anterior circulation, with or without thrombolysis; Indication for a vasographic intervention – mechanical recanalization at a stroke center; For women of childbearing potential: Willingness to use highly effective methods of contraception throughout the clinical trial and until Day 21 (inclusive) after administration of the investigational medicinal product. Given the medical condition of the enrolled patients, complete sexual abstinence appears to be the most appropriate option.
Exclusion: Participation in another clinical trial involving an investigational medicinal product within 30 days prior to screening; Signs of hypervolemia and hyperhydration or risk of their development (e.g., symptoms of acute heart failure or decompensated chronic heart failure, such as anasarca or pulmonary edema); Signs of other conditions listed as contraindications in the SmPC for Alburex (e.g., bleeding from esophageal varices or other life-threatening hemorrhage associated with anemia, renal failure /renal or post-renal/); Known hypersensitivity to albumin preparations or their excipients; Hypernatremia > 150 mmol/L; Pregnancy or breastfeeding.