Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation

Launched by FIRST AFFILIATED HOSPITAL OF FUJIAN MEDICAL UNIVERSITY · Dec 23, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients who have experienced a deep brain bleed, known as spontaneous intracerebral hemorrhage. The goal is to see if a procedure called stereotactic aspiration, combined with a medication called urokinase, is more effective than standard care in improving patients' long-term health outcomes after the bleed. The trial has two main steps: first, researchers will determine the safest and most effective dose of urokinase to use, and then they will compare the results of this combined treatment to traditional methods in patients treated within 24 hours of their symptoms starting.

To be eligible for this study, participants need to be at least 40 years old and have experienced a brain bleed that meets specific criteria, such as the bleed occurring deep in the brain and being over a certain size. Patients should also have some motor difficulties but still be able to respond, as indicated by a specific scoring system. Those with certain serious medical conditions, history of previous bleeds, or who are pregnant are not eligible. Participants will receive close monitoring and care throughout the trial, and their progress will be assessed over a year to see how well they recover.

Gender

ALL

Eligibility criteria

• 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.