Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage

Overview

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.

Full Title of Study: “Multicenter Randomized Controlled Trial of Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2018

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.

Interventions

  • Drug: Vitamin K 1
    • Research group use Vitamin K1
  • Drug: normal saline
    • Placebo group use normal saline

Arms, Groups and Cohorts

  • Experimental: research group
    • normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。
  • Placebo Comparator: placebo group
    • normal saline100ml + normal saline 2 ml ivgtt qd day0 and day1

Clinical Trial Outcome Measures

Primary Measures

  • The volume of cerebral hemorrhage
    • Time Frame: Day0
    • The volume of cerebral hemorrhage at certain time post onset(ml)
  • The volume of cerebral hemorrhage
    • Time Frame: Day3
    • The volume of cerebral hemorrhage at certain time post onset(ml)
  • The volume of cerebral hemorrhage
    • Time Frame: Day7
    • The volume of cerebral hemorrhage at certain time post onset(ml)

Secondary Measures

  • The Activated Partial Thromboplastin Time(s)at certain time post onset
    • Time Frame: Day0
    • Activated Partial Thromboplastin Time(s)
  • The Activated Partial Thromboplastin Time(s)at certain time post onset
    • Time Frame: Day3
    • Activated Partial Thromboplastin Time(s)
  • The Activated Partial Thromboplastin Time(s)at certain time post onset
    • Time Frame: Day7
    • Activated Partial Thromboplastin Time(s)
  • The condition of Platelet level at certain time post onset
    • Time Frame: Day0
    • The condition of Platelet level at certain time post onset(10^9/L)
  • The condition of Platelet level at certain time post onset
    • Time Frame: Day3
    • The condition of Platelet level at certain time post onset(10^9/L)
  • The condition of Platelet level at certain time post onset
    • Time Frame: Day7
    • The condition of Platelet level at certain time post onset(10^9/L)
  • 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 condition of GCS scale post(3-15) at certain time post onset
  • The prothrombin time(s) at certain time post onset
    • Time Frame: Day0
    • prothrombin time(s)
  • The prothrombin time(s) at certain time post onset
    • Time Frame: Day3
    • prothrombin time(s)
  • The prothrombin time(s) at certain time post onset
    • Time Frame: Day7
    • prothrombin time(s)
  • The Fibrinogen (g/L)at certain time post onset
    • Time Frame: Day0
    • Fibrinogen (g/L)
  • The Fibrinogen (g/L)at certain time post onset
    • Time Frame: Day3
    • Fibrinogen (g/L)
  • The Fibrinogen (g/L)at certain time post onset
    • Time Frame: Day7
    • Fibrinogen (g/L)
  • The Thrombin Time(s) at certain time post onset
    • Time Frame: Day0
    • Thrombin Time(s)
  • The Thrombin Time(s) at certain time post onset
    • Time Frame: Day3
    • Thrombin Time(s)
  • The Thrombin Time(s) at certain time post onset
    • Time Frame: Day7
    • Thrombin Time(s)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HUANG XIANJIAN
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: HUANG XIANJIAN, vice professor – Shenzhen Second People’s Hospital

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