Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage

January 3, 2018 updated by: HUANG XIANJIAN

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Shenzhen Second People's Hospital
      • Shenzhen, Guangdong, China, 518035
        • The fifth people's hospital of Longgang District, Shenzhen
      • Shenzhen, Guangdong, China, 518102
        • Baoan District central hospital of Shenzhen
      • Shenzhen, Guangdong, China, 518104
        • Shajing hospital of Baoan District ,Shenzhen
      • Shenzhen, Guangdong, China, 518116
        • The second People's hospital of Longgang District, Shenzhen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: research group
normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。
Drug: Vitamin K 1
Research group use Vitamin K1
Placebo Comparator: placebo group
normal saline100ml + normal saline 2 ml ivgtt qd day0 and day1
Drug: normal saline
Placebo group use normal saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The volume of cerebral hemorrhage
Time Frame: Day0
The volume of cerebral hemorrhage at certain time post onset（ml）
Day0
The volume of cerebral hemorrhage
Time Frame: Day3
The volume of cerebral hemorrhage at certain time post onset（ml）
Day3
The volume of cerebral hemorrhage
Time Frame: Day7
The volume of cerebral hemorrhage at certain time post onset（ml）
Day7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Activated Partial Thromboplastin Time（s）at certain time post onset
Time Frame: Day0
Activated Partial Thromboplastin Time（s）
Day0
The Activated Partial Thromboplastin Time（s）at certain time post onset
Time Frame: Day3
Activated Partial Thromboplastin Time（s）
Day3
The Activated Partial Thromboplastin Time（s）at certain time post onset
Time Frame: Day7
Activated Partial Thromboplastin Time（s）
Day7
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）
Day0
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）
Day3
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）
Day7
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
Day0
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
Day3
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
Day7
The prothrombin time(s) at certain time post onset
Time Frame: Day0
prothrombin time(s)
Day0
The prothrombin time(s) at certain time post onset
Time Frame: Day3
prothrombin time(s)
Day3
The prothrombin time(s) at certain time post onset
Time Frame: Day7
prothrombin time(s)
Day7
The Fibrinogen (g/L)at certain time post onset
Time Frame: Day0
Fibrinogen (g/L)
Day0
The Fibrinogen (g/L)at certain time post onset
Time Frame: Day3
Fibrinogen (g/L)
Day3
The Fibrinogen (g/L)at certain time post onset
Time Frame: Day7
Fibrinogen (g/L)
Day7
The Thrombin Time(s) at certain time post onset
Time Frame: Day0
Thrombin Time(s)
Day0
The Thrombin Time(s) at certain time post onset
Time Frame: Day3
Thrombin Time(s)
Day3
The Thrombin Time(s) at certain time post onset
Time Frame: Day7
Thrombin Time(s)
Day7

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
length of stay in ICU
Time Frame: about two weeks
length of stay in ICU
about two weeks
Total hospital stay
Time Frame: about one month
Total hospital stay
about one month
Complications1
Time Frame: 6 month post onset
neurologic complications
6 month post onset
The Modified Rankin Scale (mRS)
Time Frame: month 1 post onset

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)
Time Frame: month 6 post onset

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
Time Frame: 6 month post onset
infection complications
6 month post onset
Complications3
Time Frame: 6 month post onset
complications of coagulation
6 month post onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HUANG XIANJIAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUANGXIANJIAN20170608

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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