- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03862729
Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients (Risa-MIS-ICH)
November 19, 2021 updated by: Fuxin Lin, First Affiliated Hospital of Fujian Medical University
Risk Stratification and Minimally Invasive Surgery in Acute Intracerebral Hemorrhage Patients: a Prospective Multicenter Cohort Study (Risa-MIS-ICH Study)
The study consists of 2 parts: the first part is to conduct a multicenter retrospective analysis of more than 1000 acute ICH patients treated by conservative observation from 33 centers in China to create a predictive model of intracerebral hemorrhage growth based on clinical, blood, genetic, imaging, and pharmacological factors; the second part is to validate the efficacy of the minimally invasive surgery, including stereotactic thrombolysis and endoscopic surgery, in 300 eligible patients with high risk of hemorrhage growth according to the first part results in a prospective multicenter cohort study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Spontaneous intracerebral hemorrhage (ICH) accounts for 2 million strokes worldwide per year and is the deadliest subtype of stroke with a 1-year mortality rate up to 50%.
Given the high morbidity and mortality of this disease process, surgical options have been repeatedly evaluated in large multicenter randomized controlled trials that unfortunately have not demonstrated improved outcomes.
Time to treatment is a factor that has been shown to carry enormous weight in the treatment of ischemic stroke but has not yet been demonstrated to play a role in hemorrhagic stroke.
On the other hand, Intracerebral hemorrhage growth in early-stage is associated with the poor clinical outcome.
Thus, investigators assume that minimally invasive surgery in early-stage ICH patients with high risk of hemorrhage growth may improve the long-term outcomes.
In the first part, the investigators will review more than 1000 early-stage ICH patients from 33 centers within the last 5 years in China to create a predictive model of intracerebral hemorrhage growth based on clinical, blood, genetic, imaging, and pharmacological factors.
The "early-stage" means 24 hours from symptom onset to baseline imaging.
The "hemorrhage growth" is defined as an increase in intracerebral hemorrhage volume between baseline and repeat imaging of more than 6 mL or more than 33%.
The second part is to validate the efficacy of the minimally invasive surgery in patients with high risk of hemorrhage growth according to the first part results in a prospective multicenter cohort study.
Endoscopic surgery and stereotactic thrombolysis (150 patients) will be compared with conventional treatment (150 patients), including medical treatment and conventional craniotomy.
Clinical data and laboratory data will be collected by electric case report form (CRF) and uploaded online by each neurosurgery center to form the prospective clinical database in First Affiliated Hospital of Fujian Medical University.
This cohort follow-up study will be across a 3-year period with a 2 years interval of enrollment and 1 year follow up for each patient.
Study Type
Observational
Enrollment (Anticipated)
1300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Recruiting
- The First Affiliated Hospital of Fujian Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
In the retrospective part, at least 1000 conservatively treated acute ICH patients during the last 5 years from 31 Grade Ⅲ A level hospitals and 2 Grade Ⅱ A level hospitals distributed all over China will be enrolled.
Patients should have undergone baseline CT scan within 24 hours after hemorrhage onset and repeated fewer than 48 hours.
In the prospective part, at least 300 cute ICH patients with high risk of hemorrhage growth, according to the results of first part, from the same hospitals will be enrolled.
All patients in this study should meet the inclusion and exclusion criteria.
Informed written consent should be obtained from eligible adult patients or from the guardians of eligible pediatric patients.
All patients in the prospective part of this study can withdraw at any time.
Description
Retrospective part
Inclusion Criteria:
- Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient with a small amount of intraventricular hemorrhage is eligible);
- Patients should have undergone baseline CT scan within 48 hours after hemorrhage onset and repeated fewer than 48 hours after the baseline CT;
- Patients without herniation.
- Patients were treated by observation before hemorrhage growth (if happened).
Exclusion Criteria:
- Spontaneous intracerebral hemorrhage secondary to an underlying structural cause identified by brain imaging, (ie, vascular malformation, aneurysm, tumor);
- The time from symptom onset to baseline imaging was not known in hours, clinical information or lab results was not enough to determine the growth of the hematoma or to perform statistical analysis;
- Patients had accepted acute treatment that might have reduced intracerebral hemorrhage volume (ie, surgical evacuation, external ventricular drainage, lumbar puncture).
- Prospective part
Inclusion Criteria:
- Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient with a small amount of intraventricular hemorrhage is eligible);
- Patients without herniation meet the clinical uncertainty principle as follows: the responsible neurosurgeon is uncertain about the benefits of surgery.
- Patients should have undergone baseline CT scan within 24 hours after hemorrhage onset; the volume of the hematoma is more than 20 ml and less than 100ml on the first CT scan.
- Patients with a Glasgow coma score of 5 or more.
- Informed consent, and willing to accept long-term follow-up.
Exclusion Criteria:
- Spontaneous intracerebral hemorrhage secondary to an underlying structural cause identified by brain imaging, (ie, vascular malformation, aneurysm, tumor);
- patients had a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem;
- patients had severe pre-existing physical or mental disability or severe comorbidity that might interfere with the assessment of outcome.
- Severe coagulopathy, INR cannot be reversed to less than or equal to 1.5
- Patients during pregnancy or lactation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early minimally invasive surgery group
For patients in minimally invasive surgery group, intracranial hematoma will be removed by intraoperative stereotactic computer tomography-guided endoscopic surgery, or surgical aspiration followed by alteplase clot irrigation (1·0 mg every 8 h for up to nine doses).
CTA will be performed before operation in all the patients for intraoperative navigation, and the minimally invasive surgery will be performed within 24 hours after intracerebral hemorrhage onset.
|
Intracranial hematoma will be removed by intraoperative stereotactic computer tomography-guided endoscopic surgery, or surgical aspiration followed by alteplase clot irrigation (1·0 mg every 8 h for up to nine doses).
CTA will be performed before operation in all the patients for intraoperative navigation, and the minimally invasive surgery will be performed within 24 hours after intracerebral hemorrhage onset.
|
conventional treatment group
Eligible patients not accepting early minimally invasive surgery are classified as the conventional treatment group.
Conventional treatment includes medical treatment and conventional craniotomy.
According to the intention-to-treat principle, patients treated by minimally invasive surgery beyond the 24 hours interval after ICH onset are also classified as conventional treatment group.
|
Conventional treatment includes medical treatment and conventional craniotomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe disability or Death
Time Frame: 1 Year
|
The prespecified primary endpoints are severe disability or death defined as Barthel Index ≤60 at 1 year after intracranial hemorrhage.
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 1 year
|
Death caused by all the causes 1 year after enrollment.
|
1 year
|
Complications
Time Frame: 1 year
|
Sever complications, including pulmonary embolism, adverse cardiac events, intracranial infection, re-hemorrhage, massive cerebral infarction and brain herniation happened within 1 month after hemorrhage onset.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2019
Primary Completion (ANTICIPATED)
March 30, 2022
Study Completion (ANTICIPATED)
March 31, 2022
Study Registration Dates
First Submitted
March 3, 2019
First Submitted That Met QC Criteria
March 3, 2019
First Posted (ACTUAL)
March 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 22, 2021
Last Update Submitted That Met QC Criteria
November 19, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN-2018R002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will be available to other researchers after the main results of this study have been published.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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