Intracerebral Haemorrhage in Cerebellum Clinical Trial
Official title:
Multicenter Randomized Controlled Trial of Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
| Verified date | December 2017 |
| Source | Shenzhen Second People's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 400 |
| Est. completion date | July 1, 2019 |
| Est. primary completion date | October 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 fifth people's hospital of Longgang District, Shenzhen | Shenzhen | Guangdong |
| China | The second People's hospital of Longgang District, Shenzhen | Shenzhen | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| HUANG XIANJIAN |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | length of stay in ICU | length of stay in ICU | about two weeks | |
| Other | Total hospital stay | Total hospital stay | about one month | |
| Other | Complications1 | neurologic complications | 6 month post onset | |
| Other | The Modified Rankin Scale (mRS) | 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. |
month 1 post onset | |
| Other | The Modified Rankin Scale (mRS) | 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. |
month 6 post onset | |
| Other | Complications2 | infection complications | 6 month post onset | |
| Other | Complications3 | complications of coagulation | 6 month post onset | |
| Primary | The volume of cerebral hemorrhage | The volume of cerebral hemorrhage at certain time post onset(ml) | Day0 | |
| Primary | The volume of cerebral hemorrhage | The volume of cerebral hemorrhage at certain time post onset(ml) | Day3 | |
| Primary | The volume of cerebral hemorrhage | The volume of cerebral hemorrhage at certain time post onset(ml) | Day7 | |
| Secondary | The Activated Partial Thromboplastin Time(s)at certain time post onset | Activated Partial Thromboplastin Time(s) | Day0 | |
| Secondary | The Activated Partial Thromboplastin Time(s)at certain time post onset | Activated Partial Thromboplastin Time(s) | Day3 | |
| Secondary | The Activated Partial Thromboplastin Time(s)at certain time post onset | Activated Partial Thromboplastin Time(s) | Day7 | |
| Secondary | The condition of Platelet level at certain time post onset | The condition of Platelet level at certain time post onset(10^9/L) | Day0 | |
| Secondary | The condition of Platelet level at certain time post onset | The condition of Platelet level at certain time post onset(10^9/L) | Day3 | |
| Secondary | The condition of Platelet level at certain time post onset | The condition of Platelet level at certain time post onset(10^9/L) | Day7 | |
| Secondary | 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 | Day0 | |
| Secondary | 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 | Day3 | |
| Secondary | 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 | Day7 | |
| Secondary | The prothrombin time(s) at certain time post onset | prothrombin time(s) | Day0 | |
| Secondary | The prothrombin time(s) at certain time post onset | prothrombin time(s) | Day3 | |
| Secondary | The prothrombin time(s) at certain time post onset | prothrombin time(s) | Day7 | |
| Secondary | The Fibrinogen (g/L)at certain time post onset | Fibrinogen (g/L) | Day0 | |
| Secondary | The Fibrinogen (g/L)at certain time post onset | Fibrinogen (g/L) | Day3 | |
| Secondary | The Fibrinogen (g/L)at certain time post onset | Fibrinogen (g/L) | Day7 | |
| Secondary | The Thrombin Time(s) at certain time post onset | Thrombin Time(s) | Day0 | |
| Secondary | The Thrombin Time(s) at certain time post onset | Thrombin Time(s) | Day3 | |
| Secondary | The Thrombin Time(s) at certain time post onset | Thrombin Time(s) | Day7 |