An Early Phase 1 interventional study of Vitamin K 1 and normal saline in Intracerebral Haemorrhage in Cerebellum, sponsored by HUANG XIANJIAN. Status unknown at 5 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-04.
Sponsored by HUANG XIANJIAN · Early Phase 1, Interventional, and Treatment
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.
This is the only study on the registry with HUANG XIANJIAN as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。
Drug: Vitamin K 1
normal saline100ml + normal saline 2 ml ivgtt qd day0 and day1
Drug: normal saline
Research group use Vitamin K1
Placebo group use normal saline
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
length of stay in ICU
length of stay in ICU
Time frame: about two weeks
Total hospital stay
Total hospital stay
Time frame: about one month
Complications1
neurologic complications
Time frame: 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.
Time frame: 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.
Time frame: month 6 post onset
Complications2
infection complications
Time frame: 6 month post onset
Complications3
complications of coagulation
Time frame: 6 month post onset
PDFs hosted by the registry, ClinicalTrials.gov.
Started Aug 2017 (actual). Primary completion is estimated for Oct 2018, 14 months after the start.
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Studies of the drug tested here: Vitamin K 1