Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage (NCT04509323) | Clinical Trial Compass
UnknownPhase 4
Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage
China20 participantsStarted 2020-08-03
Plain-language summary
1. To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhageï¼›
2. To evaluate the safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage。
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged from 18 to 75 years old(including 18 and 75 years old), males or females;
✓. First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients；
✓. Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6；
✓. Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)；
✓. The patient/family knows and signs the informed consent form voluntarily.
Exclusion criteria
✕. Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination;
✕. Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma\> 5ml);
✕. Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction;
✕. Patients who use anticoagulant drugs for a long time;
✕. Patients with platelet count \<100,000, INR\>1.4 at admission and abnormal blood coagulation function;
What they're measuring
1
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment
Timeframe: At the 90-day
Trial details
NCT IDNCT04509323
SponsorJiangsu Famous Medical Technology Co., Ltd.
✕. The measured value of homocysteine at admission is higher than 15μmol/L;
✕. Patients who need surgical treatment (including ventricular drainage);
✕. Patients with severe primary diseases such as cardiovascular, liver (ALT or AST\>1.5 times the upper limit of normal), kidneys (BUN\>1.5 times the upper limit of normal and Cr\>upper limit of normal), endocrine system and hematopoietic system;