Synergistic Minimally Invasive Surgery Plus Alteplase and Deferoxamine in ICH
Status:
NOT_YET_RECRUITING
Trial end date:
2028-12-30
Target enrollment:
Participant gender:
Summary
This is a phase 2, single-center, randomized, open-label trial designed to evaluate the safety, feasibility, and preliminary efficacy of combining minimally invasive surgery (MIS) plus alteplase and intravenous deferoxamine (DFX) for the treatment of spontaneous intracerebral hemorrhage (ICH), in comparison to MIS plus alteplase alone or standard medical care. A total of 63 patients (21 per arm) will be enrolled and followed for 90 days.
Patients in the investigational arm will receive intravenous deferoxamine (DFX) at a dose of 32 mg/kg/day for 3 consecutive days, initiated immediately upon enrollment while awaiting minimally invasive surgery (MIS). The MIS procedure, once the clot is deemed stable for intervention, will involve clot aspiration followed by intralesional alteplase administration every 8 hours for up to nine doses. Patients in the standard medical care arm will be managed according to the American Heart Association (AHA) and European Stroke Organization (ESO) guidelines for acute intracerebral hemorrhage (ICH) management.
This trial will be the first to test a dual-modality approach-clot evacuation and dissolution combined with biochemical neuroprotection in ICH patients. The results will provide feasibility and safety data, generate preliminary efficacy signals, and guide the design of a future multicenter phase 3 efficacy trial.