Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05539859

Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage

To compare the efficacy and safety of neuroendoscopic hematoma removal and standard conservative treatment for patients with spontaneous supratentorial deep intracerebral hemorrhage.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intracerebral Hemorrhage Basal Ganglia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

chongqing Emergency Medical Center, Chongqing, Chongqing Municipality, China

Loading trial locations.

About this study

Neuroendoscopic treatment of spontaneous intracerebral hemorrhage (ICH) is more and more widely used, but multi-center clinical study on the efficacy and safety of neuroendoscopic treatment of ICH is relatively small. Based on the lack of sufficient clinical evidence, the investigators plan to conduct a prospective, multicenter, randomized controlled clinical trial to investigate the safety and efficacy of neuroendoscopy in the treatment of spontaneous cerebral parenchymal hemorrhage, so as to provide evidence-based medical evidence for endoscopic minimally invasive treatment of cerebral hemorrhage and its application.The aim of trial was to determine whether the endoscopic surgery could achieve the benefits of clot evacuation and improve functional outcome at 180 days after ICH without procedure-related safety events or additional brain injury beyond the risks associated with standard care

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years, either sex.
  • Time from onset to the first diagnostic CT within 24 hours (for those without bystanders and with unknown onset time, use the last known time the patient was in good condition)
  • Deep (external capsule, putamen, internal capsule, caudate nucleus) supratentorial cerebral hemorrhage with a hematoma volume ≥ 25 ml.
  • Stability of the hematoma determined by two CT scans at different times after onset. If the hematoma enlarges 5ml then the stability of the hematoma can be detected by CT again after 6 hours until the randomization time window is closed.
  • Pre-randomization GCS score of 5-14 and/or NIHSS score of ≥6.
  • Pre-onset Modified Rankin Scale (mRS) score 0 or 1.
  • Blood pressure recorded 6 hours prior to randomization consistently controlled at 180 mmHg or less.
  • Randomization completed within 24 hours after the first diagnostic CT, and surgical intervention should be performed as soon as possible, no later than 6 hours after randomization, that is to say, surgery should be performed no later than 54 hours after onset.
  • Informed and voluntarily signed informed consent by the patient or family.

Exclusion criteria

  • Hemorrhage clinically diagnosed as a result of cerebral aneurysm, cerebrovascular malformation, moyamoya disease, traumatic brain injury, brain tumor, hemorrhagic transformation of a large cerebral infarct, coagulation dysfunction.
  • Lobar hemorrhages, thalamic hemorrhages, primary ventricular hemorrhages, cerebellum hemorrhages and brain stem hemorrhages.
  • Hematoma involving the midbrain, with dilated or unresponsive pupils.
  • Hematoma producing life-threatening occupying effects (e.g., CT showing midline deviation of more than 1 cm, loss of cisterna ambiens) or patients who are extremely unstable and unfit for enrollment.
  • Platelet count <100×10^9/L, international normalized ratio (INR) >1.4.
  • Hematoma extension to ventricle and completely blocked the third or fourth ventricle.
  • Recent history of cerebral hemorrhage (less than 1 year).
  • Severe hepatic impairment with ALT 3 times the upper limit of normal, or AST 3 times the upper limit of normal. Severe renal insufficiency with glomerular filtration rate less than 30 ml/min/1.73 m2.
  • Blood pressure not effectively controlled to less than 180 mmHg despite aggressive antihypertensive therapy prior to randomization.
  • Patients with severe advanced cognitive impairment (e.g. AD) or psychiatric disorders who are unable to complete the follow-up program as required.
  • Comorbid other serious diseases such as respiratory, circulatory, digestive, urological, endocrine, immune and hematologic disorders.
  • Pregnant or lactating women, or those who expect to become pregnant within one year.

Treatment and study plan

endoscopic surgery

Procedure

Subjects will receive surgical hematoma evacuation using neuroendoscope, followed by medical management

Medical management

Other

Subjects will initially receive the standard medical therapies for the treatment of intracerebral hemorrhage, according to the latest available guideline.

Primary outcomes

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

    Time frame: 180 days

    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.

  2. Safety outcome

    Time frame: 180 days

    All cause mortality from onset to 180 days

Secondary outcomes

  1. Glasgow Outcome Scale Extended (GOS-E)

    Time frame: 30 days.

    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.

  2. Glasgow Outcome Scale Extended (GOS-E)

    Time frame: 90 days.

    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.

  3. Glasgow Outcome Scale Extended (GOS-E)

    Time frame: 180 days.

    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.

  4. Modified Rankin Scale (mRS) Score

    Time frame: 30 days.

    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.

  5. Modified Rankin Scale (mRS) Score

    Time frame: 90 days .

    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.

  6. Survival rate

    Time frame: 30 days.

    comparing the intervention group to the control

  7. Survival rate

    Time frame: 90 days.

    comparing the intervention group to the control

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

    Time frame: 30 days.

    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.

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

    Time frame: 90 days.

    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.

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

    Time frame: 180 days.

    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.

  11. Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)

    Time frame: 30 days.

    The EQ-5D-5L is a standard measure of health-related quality of life.EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health.

  12. Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)

    Time frame: 90 days.

    The EQ-5D-5L is a standard measure of health-related quality of life.EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health.

  13. Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)

    Time frame: 180 days.

    The EQ-5D-5L is a standard measure of health-related quality of life.EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health.

  14. Length of ICU

    Time frame: Number of days from admission, up to 180 days

    Duration of stay in the ICU

  15. Length of hospitalization

    Time frame: Number of days from admission to discharge, up to 180 days

    Duration of stay in the hospital

  16. In-hospital cost

    Time frame: Number of days from admission to discharge, up to 180 days

    all medical cost during the in-hospital period

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Feng, MD

CONTACT

[email protected]

8613708321681

Rong Hu, MD

CONTACT

[email protected]

8615123917123

Sponsors and collaborators

Lead sponsor

Southwest Hospital, China

Other

Registry information

Official study title

Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: a Randomised, Controlled, Open-label, Blinded Endpoint Trial

Acronym: NESICH

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 14, 2022
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.