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Tests treatment safety and results for Treatment of Spontaneous Intracerebral Hemorrhage
Official title Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation
ClinicalTrials.gov ID: NCT04686877
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- aged 40 years or older;
- the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours;
- 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 Glasgow Coma Scale (GCS) ranged from 9 to 15;
- patients with motor deficits;
You likely can't join if
- ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma;
- patients had a history of intracerebral hemorrhage or ischemic cerebral infarction;
- patients had severe coagulation disorders with INR ≥ 1.5;
- patients had severe underlying diseases, which may affect the outcomes;
- pregnant and lactating patients;
- patients refused to sign the informed consent and receive follow-up.
See the full eligibility criteria
- aged 40 years or older;
- the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours;
- 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...
- The Glasgow Coma Scale (GCS) ranged from 9 to 15;
- patients with motor deficits;
- The modified Rankin Score (mRS) ranged from 0 to1 before onset.
- ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma;
- patients had a history of intracerebral hemorrhage or ischemic cerebral infarction;
- patients had severe coagulation disorders with INR ≥ 1.5;
- patients had severe underlying diseases, which may affect the outcomes;
- pregnant and lactating patients;
- patients refused to sign the informed consent and receive follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.