Spontaneous Intracerebral HemorrhageRisa-MIS-ICHNCT03862729
Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients
An observational study of Spontaneous Intracerebral Hemorrhage, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Intracerebral Hemorrhage
- What is being tested?
- Minimally invasive surgery and conventional treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Mar 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- 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.
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- 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.
Who cannot join
- 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
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of fujian medical university
Fuzhou, Fujian, 350005
Fuxin Lin, MD, 13552358381, lfxstudy@126.com
Dezhi Kang, PHD,MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Being tested
- Minimally invasive surgery, conventional treatment
- Keywords
- Risk stratification, minimally invasive surgery, early-stage ICH patient, prospective cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgeryProcedure or 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 treatmentProcedure or surgery
Conventional treatment includes medical treatment and conventional craniotomy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Minimally invasive surgery | |
| 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. Receives: Procedure: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe disability or Death
The prespecified primary endpoints are severe disability or death defined as Barthel Index ≤60 at 1 year after intracranial hemorrhage.
Measured: 1 Year
Secondary outcomes (2)
All-cause mortality
Death caused by all the causes 1 year after enrollment.
Measured: 1 year
Complications
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jul 2019
- Primary completion30 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China
- Responsible party
- Principal investigator, Fuxin Lin, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862729
- Sponsor's protocol ID
- GN-2018R002
- Acronym
- Risa-MIS-ICH
- Status last verified
- Nov 2021
- First submitted
- 3 Mar 2019
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available to other researchers after the main results of this study have been published.
Publications
Yao S, Gao Z, Fang W, Fu Y, Xue Q, Lai T, Shangguan H, Sun W, Lin Y, Lin F, Kang D. DPA714 PET Imaging Shows That Inflammation of the Choroid Plexus Is Active in Chronic-Phase Intracerebral Hemorrhage. Clin Nucl Med. 2024 Jan 1;49(1):56-65. doi: 10.1097/RLU.0000000000004948. Epub 2023 Nov 29.
PubMed 38054504Li JB, Lin XR, Huang SN, He Q, Zheng Y, Li QX, Lin FX, Zhuo LY, Lin YX, Kang DZ, Ma K, Wang DL. High Plasma Fibrinogen Level Elevates the Risk of Cardiac Complications Following Spontaneous Intracerebral Hemorrhage. World Neurosurg. 2023 Dec;180:e774-e785. doi: 10.1016/j.wneu.2023.10.044. Epub 2023 Oct 13.
PubMed 37839573Lin F, He Q, Zhuo L, Zhao M, Ye G, Gao Z, Huang W, Cai L, Wang F, Shangguan H, Fang W, Lin Y, Wang D, Kang D. A nomogram predictive model for long-term survival in spontaneous intracerebral hemorrhage patients without cerebral herniation at admission. Sci Rep. 2023 Feb 22;13(1):3126. doi: 10.1038/s41598-022-26176-0.
PubMed 36813798Ye G, Huang S, Chen R, Zheng Y, Huang W, Gao Z, Cai L, Zhao M, Ma K, He Q, Lin F, Lin Y, Wang D, Fang W, Kang D, Wu X. Early Predictors of the Increase in Perihematomal Edema Volume After Intracerebral Hemorrhage: A Retrospective Analysis From the Risa-MIS-ICH Study. Front Neurol. 2021 Jul 27;12:700166. doi: 10.3389/fneur.2021.700166. eCollection 2021.
PubMed 34385972
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification and Minimally Invasive Surgery in Acute Intracerebral Hemorrhage Patients: a Prospective Multicenter Cohort Study (Risa-MIS-ICH Study)
- ClinicalTrials.gov ID
- NCT03862729
- Acronym / sponsor ID
- Risa-MIS-ICH / GN-2018R002
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Keywords
- Risk stratification, minimally invasive surgery, early-stage ICH patient, prospective cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early minimally invasive surgery group | – | Procedure: Minimally invasive surgeryFor 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. |
| conventional treatment group | – | Procedure: conventional treatmentEligible 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- Prospective part
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgeryIntracranial 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 or surgery | Early minimally invasive surgery group |
| conventional treatmentConventional treatment includes medical treatment and conventional craniotomy. | Procedure or surgery | conventional treatment group |
Primary outcome
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.
2 secondary outcomes
All-cause mortality
Time frame: 1 year
Complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Derived from this study: PubMed 38054504Yao S, Gao Z, Fang W, Fu Y, Xue Q, Lai T, Shangguan H, Sun W, Lin Y, Lin F, Kang D. DPA714 PET Imaging Shows That Inflammation of the Choroid Plexus Is Active in Chronic-Phase Intracerebral Hemorrhage. Clin Nucl Med. 2024 Jan 1;49(1):56-65. doi: 10.1097/RLU.0000000000004948. Epub 2023 Nov 29.
- Derived from this study: PubMed 37839573Li JB, Lin XR, Huang SN, He Q, Zheng Y, Li QX, Lin FX, Zhuo LY, Lin YX, Kang DZ, Ma K, Wang DL. High Plasma Fibrinogen Level Elevates the Risk of Cardiac Complications Following Spontaneous Intracerebral Hemorrhage. World Neurosurg. 2023 Dec;180:e774-e785. doi: 10.1016/j.wneu.2023.10.044. Epub 2023 Oct 13.
- Derived from this study: PubMed 36813798Lin F, He Q, Zhuo L, Zhao M, Ye G, Gao Z, Huang W, Cai L, Wang F, Shangguan H, Fang W, Lin Y, Wang D, Kang D. A nomogram predictive model for long-term survival in spontaneous intracerebral hemorrhage patients without cerebral herniation at admission. Sci Rep. 2023 Feb 22;13(1):3126. doi: 10.1038/s41598-022-26176-0.
- Derived from this study: PubMed 34385972Ye G, Huang S, Chen R, Zheng Y, Huang W, Gao Z, Cai L, Zhao M, Ma K, He Q, Lin F, Lin Y, Wang D, Fang W, Kang D, Wu X. Early Predictors of the Increase in Perihematomal Edema Volume After Intracerebral Hemorrhage: A Retrospective Analysis From the Risa-MIS-ICH Study. Front Neurol. 2021 Jul 27;12:700166. doi: 10.3389/fneur.2021.700166. eCollection 2021.
- Individual participant dataSharing planned: No. IPD will be available to other researchers after the main results of this study have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Intracerebral Hemorrhage, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe disability or Death (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862729, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.