Application of Fengyaokaixuan method on blood-brain barrier function and prognosis in patients with intracerebral hemorrhage by DCE-MRI

Phase 1

Recruiting

Conditions: intracerebral hemorrhage

Registration Number: ITMCTR2100004360

Lead Sponsor: Hospital (T.C.M) Affiliated to Southwest Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) The cases are in accordance with the diagnostic criteria of hemorrhagic apoplexy in traditional Chinese medicine and cerebral hemorrhage in western medicine;
(2) Aged 40 to 75 years old and the course of disease within 24 hours from the onset of the disease;
(3) No serious dysfunction of heart, liver, kidney and blood system;
(4) The site of hemorrhage: supratentorial and basal ganglia, and the hematoma did not break into the ventricle;
(5) The volume of hematoma is below 30ml;
(6) The (mRS) score of the modified Rankin scale was between 0 and 1 before onset, and the mRS score >=2 before entering the group;
(7) Those who sign the informed consent form.

Exclusion Criteria

(1) Secondary cerebral hemorrhage of various causes (including intracranial aneurysm rupture, arteriovenous malformation or tumor hemorrhage, drug-related cerebral hemorrhage, etc.); subarachnoid hemorrhage; mixed stroke; multifocal hemorrhage; basal ganglia hemorrhage breaking into the ventricle; cerebral hernia formation; midline structure shift more than 5mm; ipsilateral ventricular compression occlusion more than 1x2. The ipsilateral cistern and sulcus were blurred or disappeared, and the volume of hematoma was > 30ml;
(2) Those with a history of cerebral hemorrhage in the past six months;
(3) Patients with gastrointestinal bleeding;
(4) There are serious complications, such as heart, liver and kidney insufficiency, hematopathy, malignant tumor and severe infection, mental patients and so on;
(5) Pregnant or lactating women;
(6) Those who are allergic to any of the drug ingredients in this scheme;
(7) Those who need surgical treatment;
(8) There are metal implants in the body, claustrophobia and other patients who can not complete MRI.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rankin scale, mRS;

Secondary Outcome Measures

Name	Time	Method
Glasgow Coma Scale, GCS;parameter of blood-brain barrier permeability, Ktrans;Barthel Index, BI;National Institute of Health stroke scale, NIHSS;Recurrence rate of cerebrovascular events;variation of intracranial hematoma;