Clinical trial NCT03388970: Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
Official title: Multicenter Randomized Controlled Trial of Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Intracerebral Haemorrhage in Cerebellum
Keywords: vitamin K1
spontaneous intracerebral hemorrhage
effectiveness
outcome
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The volume of cerebral hemorrhage
timeFrame: Day0
measure: The volume of cerebral hemorrhage
timeFrame: Day3
measure: The volume of cerebral hemorrhage
timeFrame: Day7
Secondary outcomes:
measure: The Activated Partial Thromboplastin Time（s）at certain time post onset
timeFrame: Day0
measure: The Activated Partial Thromboplastin Time（s）at certain time post onset
timeFrame: Day3
measure: The Activated Partial Thromboplastin Time（s）at certain time post onset
timeFrame: Day7
measure: The condition of Platelet level at certain time post onset
timeFrame: Day0
measure: The condition of Platelet level at certain time post onset
timeFrame: Day3
measure: The condition of Platelet level at certain time post onset
timeFrame: Day7
measure: The condition of GCS scale post(3-15) at certain time post onset
timeFrame: Day0
measure: The condition of GCS scale post(3-15) at certain time post onset
timeFrame: Day3
measure: The condition of GCS scale post(3-15) at certain time post onset
timeFrame: Day7
measure: The prothrombin time(s) at certain time post onset
timeFrame: Day0
measure: The prothrombin time(s) at certain time post onset
timeFrame: Day3
measure: The prothrombin time(s) at certain time post onset
timeFrame: Day7
measure: The Fibrinogen (g/L)at certain time post onset
timeFrame: Day0
measure: The Fibrinogen (g/L)at certain time post onset
timeFrame: Day3
measure: The Fibrinogen (g/L)at certain time post onset
timeFrame: Day7
measure: The Thrombin Time(s) at certain time post onset
timeFrame: Day0
measure: The Thrombin Time(s) at certain time post onset
timeFrame: Day3
measure: The Thrombin Time(s) at certain time post onset
timeFrame: Day7
Other outcomes:
measure: length of stay in ICU
timeFrame: about two weeks
measure: Total hospital stay
timeFrame: about one month
measure: Complications1
timeFrame: 6 month post onset
measure: The Modified Rankin Scale (mRS)
timeFrame: month 1 post onset
measure: The Modified Rankin Scale (mRS)
timeFrame: month 6 post onset
measure: Complications2
timeFrame: 6 month post onset
measure: Complications3
timeFrame: 6 month post onset
Locations:
city: Shenzhen
country: China
facility: Shenzhen second people's hospital
state: Guangdong
city: Shenzhen
country: China
facility: The fifth people's hospital of Longgang District, Shenzhen
state: Guangdong
city: Shenzhen
country: China
facility: Baoan District central hospital of Shenzhen
state: Guangdong
city: Shenzhen
country: China
facility: Shajing hospital of Baoan District ,Shenzhen
state: Guangdong
city: Shenzhen
country: China
facility: The second People's hospital of Longgang District, Shenzhen
state: Guangdong
Study officials:
References: