Intracerebral Haemorrhage in Cerebellum
Conditions
Keywords
vitamin K1, spontaneous intracerebral hemorrhage, effectiveness, outcome
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.
Interventions
DRUGVitamin K 1
Research group use Vitamin K1
DRUGnormal saline
Placebo group use normal saline
Sponsors
HUANG XIANJIAN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
patient and family members
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The volume of cerebral hemorrhage | Day0 | The volume of cerebral hemorrhage at certain time post onset（ml） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Activated Partial Thromboplastin Time（s）at certain time post onset | Day0 | Activated Partial Thromboplastin Time（s） |
| The condition of Platelet level at certain time post onset | Day0 | The condition of Platelet level at certain time post onset（10\^9/L） |
| The condition of GCS scale post(3-15) at certain time post onset | Day0 | The condition of GCS scale post(3-15) at certain time post onset |
| The prothrombin time(s) at certain time post onset | Day0 | prothrombin time(s) |
| The Fibrinogen (g/L)at certain time post onset | Day0 | Fibrinogen (g/L) |
| The Thrombin Time(s) at certain time post onset | Day0 | Thrombin Time(s) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total hospital stay | about one month | Total hospital stay |
| Complications1 | 6 month post onset | neurologic complications |
| The Modified Rankin Scale (mRS) | month 1 post onset | The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. |
| Complications2 | 6 month post onset | infection complications |
| Complications3 | 6 month post onset | complications of coagulation |
| length of stay in ICU | about two weeks | length of stay in ICU |
Countries
China
Outcome results
None listed