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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Research group use Vitamin K1
Placebo group use normal saline
Shenzhen second people's hospital
Shenzhen, Guangdong, China
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
The second People's hospital of Longgang District, Shenzhen
Shenzhen, Guangdong, China
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset(ml)
Time frame: Day0
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset(ml)
Time frame: Day3
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset(ml)
Time frame: Day7
The Activated Partial Thromboplastin Time(s)at certain time post onset
Activated Partial Thromboplastin Time(s)
Time frame: Day0
The Activated Partial Thromboplastin Time(s)at certain time post onset
Activated Partial Thromboplastin Time(s)
Time frame: Day3
The Activated Partial Thromboplastin Time(s)at certain time post onset
Activated Partial Thromboplastin Time(s)
Time frame: Day7
The condition of Platelet level at certain time post onset
The condition of Platelet level at certain time post onset(10\^9/L)
Time frame: Day0
The condition of Platelet level at certain time post onset
The condition of Platelet level at certain time post onset(10\^9/L)
Time frame: Day3
The condition of Platelet level at certain time post onset
The condition of Platelet level at certain time post onset(10\^9/L)
Time frame: Day7
The condition of GCS scale post(3-15) at certain time post onset
The condition of GCS scale post(3-15) at certain time post onset
Time frame: Day0
The condition of GCS scale post(3-15) at certain time post onset
The condition of GCS scale post(3-15) at certain time post onset
Time frame: Day3
The condition of GCS scale post(3-15) at certain time post onset
The condition of GCS scale post(3-15) at certain time post onset
Time frame: Day7
The prothrombin time(s) at certain time post onset
prothrombin time(s)
Time frame: Day0
The prothrombin time(s) at certain time post onset
prothrombin time(s)
Time frame: Day3
The prothrombin time(s) at certain time post onset
prothrombin time(s)
Time frame: Day7
The Fibrinogen (g/L)at certain time post onset
Fibrinogen (g/L)
Time frame: Day0
The Fibrinogen (g/L)at certain time post onset
Fibrinogen (g/L)
Time frame: Day3
The Fibrinogen (g/L)at certain time post onset
Fibrinogen (g/L)
Time frame: Day7
The Thrombin Time(s) at certain time post onset
Thrombin Time(s)
Time frame: Day0
The Thrombin Time(s) at certain time post onset
Thrombin Time(s)
Time frame: Day3
The Thrombin Time(s) at certain time post onset
Thrombin Time(s)
Time frame: Day7
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