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| Name | Class |
|---|---|
| National Health and Family Planning Commission, P.R.China | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe disability or Death | The prespecified primary endpoints are severe disability or death defined as Barthel Index ≤60 at 1 year after intracranial hemorrhage. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Death caused by all the causes 1 year after enrollment. | 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. |
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Retrospective part
Inclusion Criteria:
Exclusion Criteria:
Prospective part
Inclusion Criteria:
Exclusion Criteria:
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In the retrospective part, at least 1000 conservatively treated acute ICH patients during the last 5 years from 31 Grade â…¢ A level hospitals and 2 Grade â…¡ 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of fujian medical university | Recruiting | Fuzhou | Fujian | 350005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38054504 | Derived | 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. | |
| 37839573 | Derived |
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IPD will be available to other researchers after the main results of this study have been published.
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| conventional treatment | Procedure | Conventional treatment includes medical treatment and conventional craniotomy. |
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| 1 year |
| Li 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. |
| 36813798 | Derived | Lin 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. |
| 34385972 | Derived | Ye 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. |