Actively Recruiting
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-02-12
400
Participants Needed
1
Research Sites
4 weeks
Total Duration
F
First Affiliated Hospital of Fujian Medical University
Lead Sponsor
D
Department of Science and Technology of Fujian province
Collaborating Sponsor
Researchers are evaluating early minimally invasive treatment for deep-seated spontaneous cerebral hemorrhage (dICH) in this nationwide, multicenter, open-label, randomized controlled trial. The study aims to determine the safety and optimal dose of urokinase intra-hematoma irrigation after stereotactic aspiration and to assess whether this combined approach improves long-term outcomes compared to conservative treatment in patients treated within 24 hours of dICH onset. The trial builds on previous research and focuses on improving recovery for patients with this serious brain condition. The study has two parts. The first part tests different doses of urokinase to find the safest and most effective amount for irrigation after stereotactic aspiration. The second part randomly assigns eligible patients to either the STAPLE group, which receives stereotactic CTA-guided aspiration and urokinase irrigation within 36 hours of symptom onset, or the conservative treatment group following standard guidelines. CT scans and urokinase doses are adjusted based on follow-up imaging. Patients in the conservative group receive routine care, with surgery considered if their condition worsens. Participants will be closely monitored during hospitalization with demographic, medical, and treatment data recorded. Follow-up includes CT scans and neurological exams at 30 and 365 days after randomization, plus phone check-ins at 90, 180, and 270 days. Researchers will measure functional outcomes using scales such as the modified Rankin Scale, Glasgow Outcome Score, and Barthel Index, along with hematoma volume changes and mortality rates to evaluate treatment impact and safety over one year.
CONDITIONS
Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 7 days post-operation or treatment initiation
Participants receive either stereotactic aspiration plus urokinase clot irrigation within 36 hours of symptom onset or conservative treatment according to clinical guidelines. Surgery and urokinase injections are administered based on CT scans and clinical condition.
CT scans on days 1, 3, 5, and 7 post-operation for the STAPLE group
Duration - 1 year
Participants are followed up to assess neurological outcomes, survival, and safety through outpatient visits and phone calls over one year.
Outpatient visits at days 30 and 365; phone follow-ups at days 90, 180, and 270
Total: 1 location
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
L
Lin Fuxin, PHD,MD
K
Kang Dezhi, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Ziwei Yan, Lai Jiang, Gang Li...
https://pubmed.ncbi.nlm.nih.gov/39227662