Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSouthwest Hospital, China

About this trial

This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old, male or female;

The time between onset and admission to the first diagnostic CT is within 24 hours (for no bystanders and the time of onset is unknown, the time of the last known patient in good condition is used);

Patients with supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage) whose hematoma volume is ≥50ml or whose hematoma produces obvious space occupying effect and requires emergency surgery (including patients with cerebral hernia signs such as retarding or dilatation of light reflex of one pupil);

Before randomization, GCS score was 5-14, NIHSS score was ≥6;

Disqualifiers

The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.;

Thalamic hemorrhage, primary ventricular hemorrhage;

Platelet count <100×109/L, INR > 1.4;

Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

  • neuroendoscopic surgery

    Procedure/Surgery

    Subjects will receive Neuroendoscopic Surgery followed by standard medical management

  • craniotomy

    Procedure/Surgery

    Subjects will receive Craniotomy followed by standard medical management

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients with Modified Rankin Scale (mRS) score 0-3

Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

Time frame
180 days

Secondary outcomes

1

Modified Rankin Scale (mRS) Score

The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

Time frame
180 days
2

mortality

All cause mortality from onset to 180 days

Time frame
30 days, 90 days and 180 days
3

Glasgow Outcome Scale Extended (GOS-E)

GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.

Time frame
180 days
4

Assessment of cognitive function with Mini-Mental State Examination (MMSE)

The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function.

Time frame
90 days and 180 days

Other outcomes

Sponsors and contacts

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