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

Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05687201
• Other study ID #: HL970570
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: The Affiliated Hospital Of Guizhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of ICH confirmed by non-enhanced CT scan.

• ICH volume less than 85ml.

• The apolipoprotein genotypes of the patients were APOE-e3 and APOE-e4 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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Diagnostic Test:
• Non-enhanced CT scan?Nuclear Magnetic Resonance (MRI)
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.

Locations

Country	Name	City	State
China	Computed Tomography	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital Of Guizhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of perihematoma edema	Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.	Days 1 after ICH
Primary	Changes in the volume of perihematoma edema	Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.	Days 3 after ICH
Primary	Changes in the volume of perihematoma edema	Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.	Days 7 after ICH
Primary	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	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
Secondary	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
Secondary	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