Status:
UNKNOWN
Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
Lead Sponsor:
HUANG XIANJIAN
Conditions:
Intracerebral Haemorrhage in Cerebellum
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03388970
Start Date
August 1 2017
End Date
July 1 2019
Last Update
January 4 2018
Active Locations (5)
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1
Shenzhen second people's hospital
Shenzhen, Guangdong, China, 518000
2
The fifth people's hospital of Longgang District, Shenzhen
Shenzhen, Guangdong, China, 518035
3
Baoan District central hospital of Shenzhen
Shenzhen, Guangdong, China, 518102
4
Shajing hospital of Baoan District ,Shenzhen
Shenzhen, Guangdong, China, 518104