Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
Multicenter Randomized Controlled Trial of Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
1 other identifier
interventional
400
1 country
5
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2017
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJanuary 4, 2018
December 1, 2017
1.2 years
October 29, 2017
January 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset（ml）
Day0
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset（ml）
Day3
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset（ml）
Day7
Secondary Outcomes (18)
The Activated Partial Thromboplastin Time（s）at certain time post onset
Day0
The Activated Partial Thromboplastin Time（s）at certain time post onset
Day3
The Activated Partial Thromboplastin Time（s）at certain time post onset
Day7
The condition of Platelet level at certain time post onset
Day0
The condition of Platelet level at certain time post onset
Day3
- +13 more secondary outcomes
Other Outcomes (7)
length of stay in ICU
about two weeks
Total hospital stay
about one month
Complications1
6 month post onset
- +4 more other outcomes
Study Arms (2)
research group
EXPERIMENTALnormal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。
placebo group
PLACEBO COMPARATORnormal saline100ml + normal saline 2 ml ivgtt qd day0 and day1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HUANG XIANJIANlead
Study Sites (5)
Shenzhen second people's hospital
Shenzhen, Guangdong, 518000, China
The fifth people's hospital of Longgang District, Shenzhen
Shenzhen, Guangdong, 518035, China
Baoan District central hospital of Shenzhen
Shenzhen, Guangdong, 518102, China
Shajing hospital of Baoan District ,Shenzhen
Shenzhen, Guangdong, 518104, China
The second People's hospital of Longgang District, Shenzhen
Shenzhen, Guangdong, 518116, China
Related Publications (1)
Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
PMID: 37870112DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- patient and family members
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- vice professor
Study Record Dates
First Submitted
October 29, 2017
First Posted
January 3, 2018
Study Start
August 1, 2017
Primary Completion
October 31, 2018
Study Completion
July 1, 2019
Last Updated
January 4, 2018
Record last verified: 2017-12