Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

In order to determine the effectiveness and safety of early vitamin K1 use in reducing the risk of bleeding and improving prognosis in patients with spontaneous intracerebral hemorrhage. Patients with spontaneous intracerebral hemorrhage (excluding rupture of aneurysm and vascular malformation) will be randomly divided into experimental group and control group. All the patients in the two groups were treated according to the guideline of spontaneous intracerebral hemorrhage. Patients in the experimental group was treated with intravenous injection of vitamin K1 20mg once a day for 2 days after admission, and the patients in control group was treated with normal saline as a control. The hematoma volume, coagulation function, platelet levels and GCS scales of the two groups will be recorded in 0d, 1d, 3d, 7d post bleeding stroke, furthermore, length of ICU stay and total hospitalization, incidence of complications during hospitalization are to be recorded. During the follow-up, mRS score will be recorded at 1m and 6m post bleeding stroke.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HUANG XIANJIAN
• Treatments: Vitamin K; Vitamin K 1

Criteria

Inclusion Criteria:

• Spontaneous intracerebral hemorrhage (Non - aneurysmal or arteriovenous malformations which confirmed by cerebral arterial CT enhancement or DSA);

• Age 18-65 years, male or non-pregnant female;

• GCS score at admission (4 to12);

• during the hospitalization, no urokinase and other hemostatic drugs were used except for etamsylate and vitamin K1;

• informed consent signed by the patient's family

Exclusion Criteria:

• irregular lobulated hematoma (volume of hematoma can not be calculated accurately), such as intraventricular hemorrhage;

• severe liver disease or impaired liver function;

• pregnant or lactating women;

• history of using anticoagulation or antiplatelet aggregation drug (including Cilostazol, aspirin, dipyridamole, heparin, low molecular weight heparin, hirudin, dabigatran, and warfarin);

• non-accepted informed consent