Intracerebral Haemorrhage in CerebellumEarly Phase 1NCT03388970
Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
A Early Phase 1 study testing Vitamin K 1 and normal saline in people with Intracerebral Haemorrhage in Cerebellum, run by HUANG XIANJIAN at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracerebral Haemorrhage in Cerebellum
- What is being tested?
- Vitamin K 1 and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2017to 1 Jul 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Shenzhen second people's hospital
Shenzhen, Guangdong, 518000
The fifth people's hospital of Longgang District, Shenzhen
Shenzhen, Guangdong, 518035
Baoan District central hospital of Shenzhen
Shenzhen, Guangdong, 518102
Shajing hospital of Baoan District ,Shenzhen
Shenzhen, Guangdong, 518104
The second People's hospital of Longgang District, Shenzhen
Shenzhen, Guangdong, 518116
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracerebral Haemorrhage in Cerebellum
- Being tested
- Vitamin K 1, normal saline
- Keywords
- vitamin K1, spontaneous intracerebral hemorrhage, effectiveness, outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K 1Drug
Research group use Vitamin K1
normal salineDrug
Placebo group use normal saline
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。 Receives: Drug: Vitamin K 1 |
| placebo group | Placebo comparator | normal saline100ml + normal saline 2 ml ivgtt qd day0 and day1 Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset（ml）
Measured: Day0
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset（ml）
Measured: Day3
The volume of cerebral hemorrhage
The volume of cerebral hemorrhage at certain time post onset（ml）
Measured: Day7
Secondary outcomes (18)
The Activated Partial Thromboplastin Time（s）at certain time post onset
Activated Partial Thromboplastin Time（s）
Measured: Day0
The Activated Partial Thromboplastin Time（s）at certain time post onset
Activated Partial Thromboplastin Time（s）
Measured: Day3
The Activated Partial Thromboplastin Time（s）at certain time post onset
Activated Partial Thromboplastin Time（s）
Measured: Day7
The condition of Platelet level at certain time post onset
The condition of Platelet level at certain time post onset（10^9/L）
Measured: Day0
The condition of Platelet level at certain time post onset
The condition of Platelet level at certain time post onset（10^9/L）
Measured: Day3
The condition of Platelet level at certain time post onset
The condition of Platelet level at certain time post onset（10^9/L）
Measured: Day7
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
Measured: 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
Measured: 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
Measured: Day7
The prothrombin time(s) at certain time post onset
prothrombin time(s)
Measured: Day0
The prothrombin time(s) at certain time post onset
prothrombin time(s)
Measured: Day3
The prothrombin time(s) at certain time post onset
prothrombin time(s)
Measured: Day7
The Fibrinogen (g/L)at certain time post onset
Fibrinogen (g/L)
Measured: Day0
The Fibrinogen (g/L)at certain time post onset
Fibrinogen (g/L)
Measured: Day3
The Fibrinogen (g/L)at certain time post onset
Fibrinogen (g/L)
Measured: Day7
The Thrombin Time(s) at certain time post onset
Thrombin Time(s)
Measured: Day0
The Thrombin Time(s) at certain time post onset
Thrombin Time(s)
Measured: Day3
The Thrombin Time(s) at certain time post onset
Thrombin Time(s)
Measured: Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Aug 2017
- Primary completion31 Oct 2018 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral Haemorrhage in CerebellumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUANG XIANJIAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HUANG XIANJIAN, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388970
- Sponsor's protocol ID
- HUANGXIANJIAN20170608
- Status last verified
- Dec 2017
- First submitted
- 29 Oct 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37870112
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial of Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT03388970
- Acronym / sponsor ID
- HUANGXIANJIAN20170608
- Conditions
- Intracerebral Haemorrhage in Cerebellum
- Keywords
- vitamin K1, spontaneous intracerebral hemorrhage, effectiveness, outcome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- HUANG XIANJIANUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Drug: Vitamin K 1normal saline 100ml+ vitamin K1 20mg ivgtt qd day0 and day1。 |
| placebo group | Placebo comparator | Drug: normal salinenormal saline100ml + normal saline 2 ml ivgtt qd day0 and day1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K 1Research group use Vitamin K1 | Drug | research group |
| normal salinePlacebo group use normal saline | Drug | placebo group |
Primary outcome
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）
18 secondary outcomes
The Activated Partial Thromboplastin Time（s）at certain time post onset
Time frame: Day0
The Activated Partial Thromboplastin Time（s）at certain time post onset
Time frame: Day3
The Activated Partial Thromboplastin Time（s）at certain time post onset
Time frame: Day7
The condition of Platelet level at certain time post onset
Time frame: Day0
The condition of Platelet level at certain time post onset
Time frame: Day3
The condition of Platelet level at certain time post onset
Time frame: 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
Time frame: Day3
The condition of GCS scale post(3-15) at certain time post onset
Time frame: Day7
The prothrombin time(s) at certain time post onset
Time frame: Day0
The prothrombin time(s) at certain time post onset
Time frame: Day3
The prothrombin time(s) at certain time post onset
Time frame: Day7
The Fibrinogen (g/L)at certain time post onset
Time frame: Day0
The Fibrinogen (g/L)at certain time post onset
Time frame: Day3
The Fibrinogen (g/L)at certain time post onset
Time frame: Day7
The Thrombin Time(s) at certain time post onset
Time frame: Day0
The Thrombin Time(s) at certain time post onset
Time frame: Day3
The Thrombin Time(s) at certain time post onset
Time frame: Day7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Derived from this study: PubMed 37870112Eilertsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin K 1 and normal saline in people with Intracerebral Haemorrhage in Cerebellum, run by HUANG XIANJIAN at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volume of cerebral hemorrhage (time frame: Day0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.