Effect of Apolipoprotein E on the Prognosis of Patients With Intracerebral Hemorrhage

Study Overview
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Brief Summary
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The purpose of this observational study was to compare perihematomal edema and short-term prognosis in patients with intracerebral hemorrhage carrying the APOE-ε3 and APOE-ε4 genes. The main questions it aims to answer are: Exploring whether patients carrying the ApoE-ε4 gene have more perifocal perihematomal edema after intracerebral hemorrhage than patients with the ApoE-ε3 gene. ApoEε4 gene has worse short-term prognosis than ApoEε3 gene in intracerebral hemorrhage patients. All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.Some ICH patients were evaluated for Stereotactic minimally invasive surgery (sMIS) treatment by two experienced neurosurgeons.

Official Title
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Effect of Apolipoprotein E4 on Perihematomal Edema and Short-term Prognosis in Patients With Intracerebral Hemorrhage

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Diagnostic Test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ICH confirmed by non-enhanced CT scan. ICH volume less than 85ml. The apolipoprotein genotypes of the patients were APOE-ε3 and APOE-ε4 by venous blood sampling. Exclusion Criteria: Patients with ICH due to trauma, anticoagulation therapy, or antiplatelet therapy were excluded. The patients with ICH volume greater than 85 ml were excluded. Admission with diseases that may affect the inflammatory response, such as: infectious meningitis, systemic infections, etc. Stroke patients with previous residual neurological deficits.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| APOE-E4 (ε2/ε4,ε3/ε4,ε4/ε4) group<br>All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.In addition, all patients received more comprehensive measures to prevent deep vein thrombosis (DVT), control blood pressure and glucose, nutritional support, and prevent other complications. | Diagnostic Test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)<br>* Non-surgical patients were followed up by CT on days 1, 3, and 5 after ICH, and by CT or MRI on day 7.Surgical patients were followed up by CT before surgery and then transferred to the operating room.The first postoperative follow-up CT scan was performed on the second day after surgery, and the second postoperative CT scan was performed on the third day after surgery. Some patients need a third or even a fourth CT follow-up after surgery. The CT scan can be repeated at any time if the patient has neurologic deterioration.<br>|
| APOEε3(ε3/ε3) group<br>All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.In addition, all patients received more comprehensive measures to prevent deep vein thrombosis (DVT), control blood pressure and glucose, nutritional support, and prevent other complications. | Diagnostic Test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)<br>* Non-surgical patients were followed up by CT on days 1, 3, and 5 after ICH, and by CT or MRI on day 7.Surgical patients were followed up by CT before surgery and then transferred to the operating room.The first postoperative follow-up CT scan was performed on the second day after surgery, and the second postoperative CT scan was performed on the third day after surgery. Some patients need a third or even a fourth CT follow-up after surgery. The CT scan can be repeated at any time if the patient has neurologic deterioration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of perihematoma edema | Calculation of perihematoma edema volume after ICH by non-enhanced CT scan. | Days 1 after ICH | 
| Changes in the volume of perihematoma edema | Calculation of perihematoma edema volume after ICH by non-enhanced CT scan. | Days 3 after ICH | 
| Changes in the volume of perihematoma edema | Calculation of perihematoma edema volume after ICH by non-enhanced CT scan. | Days 7 after ICH | 
| Discharge and 90 days Modified Rankin Scale (mRS) score | Telephone follow-up by experienced neurologist.Defining a modified Rankin Scale (mRS) score of 0-3 at discharge was considered to be a good prognosis. If the mRS score was >3, the prognosis was considered poor. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous blood biochemical parameter | Neutrophil test in venous blood drawn within 24 hours of the onset of ICH (neutrophil levels in ×10^9/L) | Within 24h of the onset of ICH | 
| Venous blood biochemical parameter | Lymphocyte test in venous blood drawn within 24 hours of the onset of ICH (lymphocyte levels in ×10^9/L) | Within 24h of the onset of ICH | 
| Venous blood biochemical parameter | Platelet test in venous blood drawn within 24 hours of the onset of ICH (platelet levels in ×10^9/L) | Within 24h of the onset of ICH | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracerebral Hemorrhage, Apolipoprotein E, Perihematomal edema, Prognosis