Neuroprotectant for Hypertensive Intracerebral Hemorrhage

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a compound preparation of muscle extract from healthy rabbits and cattle brain gangliosides, which was approved by the Chinese Food and Drug Administration in 2011 and was commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China. To evaluate the safety and efficacy of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rong Hu, MD
• Treatments: Cardiac Glycosides; Neuroprotective Agents

Criteria

Inclusion Criteria:

1. Individuals aged 18-75 years;

2. Newly diagnosed hypertensive intracerebral hemorrhage, bleeding position localizes in Basal ganglia and bleeding volume is within 25-50ml evaluated by head CT, and the hemorrhage does not break into lateral ventricle;

3. Obvious neurological dysfunction after onset, Glasco Comma Scale evaluation between 5-14, or NIHSS above 6, but without signs of cerebral hernia.

4. Enrolled within 72 hours after onset, and CT examination shows no hematomas expansion within 6 hours or above after diagnostic CT (hematoma expansion ≤ 5ml);

5. Written informed consent can be obtained.

Exclusion Criteria:

1. Diagnosed with intracerebral hemorrhage caused by aneurysm, brain tumor, trauma, cerebral parasitic disease, cerebrovascular malformation, moyamoya disease, cerebral arteritis, hematological diseases, or metabolic disorders;

2. Patients whose hematoma is unstable or progress leading to increased intracranial pressure;

3. Ever diagnosed with subarachnoid hemorrhage and ischemic stroke;

4. Ever received anticoagulants or antiplatelet drug treatment within one month prior to onset;

5. Abnormal coagulation function (platelet count <100×109/L, INR>1.4);

6. Patients who need operation treatment (including external ventricular drainage);

7. Patients who may suffer from mental or physical diseases that disturb outcome evaluation;

8. blood homocysteine higher than 15μmol/L when admission;

9. Patients who have serious diseases in heart, lung, liver, kidney, endocrine or hemopoietic system;

10. Allergic to protein or peptide;

11. Drug or alcohol addiction;

12. Pregnant women (positive in pregnancy test or lactating women)

13. Participated in other clinical trials within 3 months;

14. Patients considered as not suitable for clinical trials by researchers.