First Affiliated Hospital of Fujian Medical University
Phase
Not applicable
Started
2021-01-31
Last updated
2025-02-12
Condition(s) studied
Treatment of Spontaneous Intracerebral Hemorrhage
Investigational drug(s) / intervention(s)
STAPLE
STAPLE: Stereotactic aspiration plus urokinase clot irrigation
Study summary
This is a nationwide, multicenter, open-label, randomized controlled trial of early minimally invasive treatment for deep-seated spontaneous cerebral hemorrhage (dICH). The study consists of 2 steps: the first step is to conduct a dose climbing test to determine the safety and optimal dose of urokinase intra-hematoma irrigation after stereotactic aspiration; the second step is to validate whether stereotactic aspiration plus urokinase irrigation (the optimal dose determined in step one) is superior to conservative treatment in improving long-term outcomes (1 year) in early (within 24h) dICH patients.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
1. aged 40 years or older;
2. the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours;
3. patients with a spontaneous ICH in the deep brain parenchyma (≥1 cm from the cortical surface); with hematoma volume more than 25 ml (measured with the ABC/2 method); without hydrocephalus caused by intraventricular hemorrhage; without cerebral herniation and the benefit of surgical treatment was unknown;
4. The Glasgow Coma Scale (GCS) ranged from 9 to 15;
5. patients with motor deficits;
6. The modified Rankin Score (mRS) ranged from 0 to1 before onset.
Exclusion Criteria:
1. ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma;
2. patients had a history of intracerebral hemorrhage or ischemic cerebral infarction;
3. patients had severe coagulation disorders with INR ≥ 1.5;
4. patients had severe underlying diseases, which may affect the outcomes;
5. pregnant and lactating patients;
6. patients refused to sign the informed consent and receive follow-up.
Primary outcome measure(s)
Good functional outcome, measured by the modified Rankin Scale (mRS) — At day 365 after randomization Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome (yes/no, final value). In this context, a mRS score of 3 points reflects the ability to walk unassisted and care for one's own bodily needs despite being moderately dependent on assistance, while a mRS score of 4 points describes a patient who is not able to walk anymore and needs assistance with all daily activities and thus marks a severe loss of patient autonomy.
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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