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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| research group | Experimental | normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。 |
|
| placebo group | Placebo Comparator | normal saline100ml + normal saline 2 ml ivgtt qd day0 and day1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K 1 | Drug | Research group use Vitamin K1 |
| |
| normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| The volume of cerebral hemorrhage | The volume of cerebral hemorrhage at certain time post onset(ml) | Day0 |
| The volume of cerebral hemorrhage | The volume of cerebral hemorrhage at certain time post onset(ml) | Day3 |
| The volume of cerebral hemorrhage | The volume of cerebral hemorrhage at certain time post onset(ml) | Day7 |
| Measure | Description | Time Frame |
|---|---|---|
| The Activated Partial Thromboplastin Time(s)at certain time post onset | Activated Partial Thromboplastin Time(s) | Day0 |
| The Activated Partial Thromboplastin Time(s)at certain time post onset | Activated Partial Thromboplastin Time(s) |
| Measure | Description | Time Frame |
|---|---|---|
| length of stay in ICU | length of stay in ICU | about two weeks |
| Total hospital stay | Total hospital stay | about one month |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen second people's hospital | Shenzhen | Guangdong | 518000 | China | ||
| The fifth people's hospital of Longgang District, Shenzhen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870112 | Derived | Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2017 | Oct 29, 2017 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2017 | Oct 29, 2017 | ICF_001.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 29, 2017 | Oct 29, 2017 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D010837 | Vitamin K 1 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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patient and family members
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| Drug |
Placebo group use normal saline |
|
| Day3 |
| The Activated Partial Thromboplastin Time(s)at certain time post onset | Activated Partial Thromboplastin Time(s) | Day7 |
| The condition of Platelet level at certain time post onset | The condition of Platelet level at certain time post onset(10^9/L) | Day0 |
| The condition of Platelet level at certain time post onset | The condition of Platelet level at certain time post onset(10^9/L) | Day3 |
| The condition of Platelet level at certain time post onset | The condition of Platelet level at certain time post onset(10^9/L) | 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 | 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 | 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 | Day7 |
| The prothrombin time(s) at certain time post onset | prothrombin time(s) | Day0 |
| The prothrombin time(s) at certain time post onset | prothrombin time(s) | Day3 |
| The prothrombin time(s) at certain time post onset | prothrombin time(s) | Day7 |
| The Fibrinogen (g/L)at certain time post onset | Fibrinogen (g/L) | Day0 |
| The Fibrinogen (g/L)at certain time post onset | Fibrinogen (g/L) | Day3 |
| The Fibrinogen (g/L)at certain time post onset | Fibrinogen (g/L) | Day7 |
| The Thrombin Time(s) at certain time post onset | Thrombin Time(s) | Day0 |
| The Thrombin Time(s) at certain time post onset | Thrombin Time(s) | Day3 |
| The Thrombin Time(s) at certain time post onset | Thrombin Time(s) | Day7 |
| Complications1 | neurologic complications | 6 month post onset |
| 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 |
| 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 |
| Complications2 | infection complications | 6 month post onset |
| Complications3 | complications of coagulation | 6 month post onset |
| Shenzhen |
| Guangdong |
| 518035 |
| China |
| Baoan District central hospital of Shenzhen | Shenzhen | Guangdong | 518102 | China |
| Shajing hospital of Baoan District ,Shenzhen | Shenzhen | Guangdong | 518104 | China |
| The second People's hospital of Longgang District, Shenzhen | Shenzhen | Guangdong | 518116 | China |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |