Risa-MIS-ICH: Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients

Sponsor

First Affiliated Hospital of Fujian Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03862729

Collaborator

National Health and Family Planning Commission, P.R.China (Other)

1,300

Enrollment

Location

Anticipated Duration (Months)

39.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Intracerebral Hemorrhage	Procedure: Minimally invasive surgery Procedure: conventional 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Risk Stratification and Minimally Invasive Surgery in Acute Intracerebral Hemorrhage Patients: a Prospective Multicenter Cohort Study (Risa-MIS-ICH Study)

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	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.	Procedure: Minimally invasive surgery 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.	Procedure: conventional treatment Conventional treatment includes medical treatment and conventional craniotomy.

Arm

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.

Procedure: Minimally invasive surgery

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.

Procedure: conventional treatment

Conventional treatment includes medical treatment and conventional craniotomy.

Outcome Measures

Primary Outcome Measures

Severe disability or Death [1 Year]
The prespecified primary endpoints are severe disability or death defined as Barthel Index ≤60 at 1 year after intracranial hemorrhage.

Secondary Outcome Measures

All-cause mortality [1 year]
Death caused by all the causes 1 year after enrollment.
Complications [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.