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临床试验/NCT03388970
NCT03388970Unknown早期 1 期

Multicenter Randomized Controlled Trial of Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage

HUANG XIANJIAN5 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
400
试验地点
5
主要终点
The volume of cerebral hemorrhage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

patient and family members

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

research group

Experimental

normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。

干预措施: Vitamin K 1 (Drug)

placebo group

Placebo Comparator

normal saline100ml + normal saline 2 ml ivgtt qd day0 and day1

干预措施: normal saline (Drug)

结局指标

主要结局

The volume of cerebral hemorrhage

时间窗: Day7

The volume of cerebral hemorrhage at certain time post onset(ml)

次要结局

  • The condition of GCS scale post(3-15) at certain time post onset(Day7)
  • The Thrombin Time(s) at certain time post onset(Day7)
  • The Activated Partial Thromboplastin Time(s)at certain time post onset(Day7)
  • The condition of Platelet level at certain time post onset(Day7)
  • The prothrombin time(s) at certain time post onset(Day7)
  • The Fibrinogen (g/L)at certain time post onset(Day7)

研究者

发起方
HUANG XIANJIAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

HUANG XIANJIAN

vice professor

Shenzhen Second People's Hospital

研究点 (5)

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