Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
- Conditions
- Intracerebral Haemorrhage in Cerebellum
- Interventions
- Drug: normal saline
- Registration Number
- NCT03388970
- Lead Sponsor
- HUANG XIANJIAN
- Brief 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.
- Detailed Description
Spontaneous intracerebral hemorrhage is a common disease in the department of neurosurgery, which often leads to long-term coma and severe neurological dysfunction. The amount of cerebral hemorrhage is directly related to the prognosis of the patients, and a small number of patients still suffer from the adverse consequences of delayed bleeding after active treatment. Vitamin K1 is a necessary ingredient in the liver to produce clotting factors II, VII, IX, and X, and vitamin K1 supplementation increases clotting function. On the contrary, vitamin K1 increases the risk of thrombosis. In this study, 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. Finally, the effectiveness and safety of early vitamin K1 use in reducing the risk of bleeding and improving prognosis in patients with spontaneous intracerebral hemorrhage will be analyzed.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group normal saline normal saline100ml + normal saline 2 ml ivgtt qd day0 and day1 research group Vitamin K 1 normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。
- Primary Outcome Measures
Name Time Method The volume of cerebral hemorrhage Day7 The volume of cerebral hemorrhage at certain time post onset（ml）
- Secondary Outcome Measures
Name Time Method The prothrombin time(s) at certain time post onset Day7 prothrombin time(s)
The condition of GCS scale post(3-15) at certain time post onset Day7 The condition of GCS scale post(3-15) at certain time post onset
The Thrombin Time(s) at certain time post onset Day7 Thrombin Time(s)
The Activated Partial Thromboplastin Time（s）at certain time post onset Day7 Activated Partial Thromboplastin Time（s）
The condition of Platelet level at certain time post onset Day7 The condition of Platelet level at certain time post onset（10\^9/L）
The Fibrinogen (g/L)at certain time post onset Day7 Fibrinogen (g/L)
Trial Locations
- Locations (5)
The fifth people's hospital of Longgang District, Shenzhen
🇨🇳Shenzhen, Guangdong, China
Baoan District central hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Shajing hospital of Baoan District ,Shenzhen
🇨🇳Shenzhen, Guangdong, China
Shenzhen second people's hospital
🇨🇳Shenzhen, Guangdong, China
The second People's hospital of Longgang District, Shenzhen
🇨🇳Shenzhen, Guangdong, China