Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06429553

Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage

Led by Anhui Provincial Hospital · Updated on 2024-05-28

100

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To observe the effect of minimally invasive intracranial hematoma aspiration and drainage combined with urokinase injection and drug therapy on prognosis of spontaneous cerebral hemorrhage.

CONDITIONS

Official Title

Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 80 years
  • Diagnosed with intracerebral hemorrhage in the basal ganglia by head CT scan
  • Hematoma volume between 20 and 40 mL with less than 3 mm horizontal midline shift
  • Time from onset to randomization within 48 hours
  • Glasgow Coma Scale score between 4 and 14 at randomization
  • National Institutes of Health Stroke Scale score of 6 or higher at randomization
  • Muscle strength grade 0 to 3 in unilateral limbs on the symptomatic side
  • Modified Rankin Scale score 0 to 1 before onset
  • Systolic blood pressure controlled below 180 mmHg before randomization
  • Written informed consent signed by the patient and legal representative
Not Eligible

You will not qualify if you...

  • Bleeding in areas other than basal ganglia such as thalamus, brain stem, or cerebellum
  • Bleeding caused by aneurysm, arteriovenous malformation, brain trauma, brain tumor, massive cerebral infarction, amyloidosis, or coagulation disorders
  • History of cerebral hemorrhage within the past year
  • Multiple intracranial hemorrhages
  • Early signs of expanding intracerebral hemorrhage hematoma on CTA imaging
  • Ventricular hemorrhage or intrusion requiring external ventricular drainage
  • History of intracranial bleeding or surgery within the last 30 days
  • Coagulation dysfunction or low blood counts (hemoglobin, hematocrit, platelets)
  • Use of anticoagulant drugs within one week before enrollment with high INR
  • Expected long-term anticoagulant or antiplatelet therapy
  • Uncontrolled internal bleeding or recent myocardial infarction
  • High risk of embolism from specific heart conditions
  • Severe liver or kidney dysfunction
  • Hypertension not controlled before randomization (systolic BP > 180 mmHg)
  • Inability to complete follow-up due to mental illness or Alzheimer’s disease
  • Serious diseases affecting respiratory, circulatory, digestive, genitourinary, endocrine, immune, or blood systems
  • Current drug or alcohol abuse or dependence
  • Allergy to urokinase or surgery-related drugs or instruments
  • Pregnant, lactating, or planning pregnancy within one year
  • Life expectancy less than 12 months
  • Participation in other clinical trials or prior inclusion in this trial
  • No willingness to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hao Xu

Hefei, Anhui, China, 230001

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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