Coagulation Factor DeficiencyVITAKOAGNCT03782025
Effect of Vitamin K in Critically Ill Patients
An observational study of Coagulation Factor Deficiency and Coagulopathy, Consumption, run by Region Skane at 2 sites in Sweden.
Trial summary
Critically ill patients with spontaneously prolonged pro-thrombin time, where administration of intravenous administration of phytomenadione (vitamin K) has been ordered by the treating physician will be identified. After signed informed consent baseline samples will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Factor Deficiency, Coagulopathy, Consumption, Vitamin K Deficiency
- What is being tested?
- Phytomenadione
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 2 sitesSweden
- Study dates
- 13 Feb 2019to 20 Mar 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients at the postoperative care unit or at the intensive care unit with a prothrombin complex (PK-INR) > 1.2 during office hours who are ordered parenteral phytomenadione 10 mg will be eligible for inclusion
Who may be able to join
- Critically ill patients at the postoperative care unit or at the intensive care unit with a prothrombin complex (PK-INR) > 1.2 during office hours who are ordered parenteral phytomenadione 10 mg will be eligible for inclusion
Who cannot join
- Warfarin treatment
- Treatment with novel oral anticoagulants
- Hepatocellular carcinoma
- Liver resection within 6 months
- Known pre-existing coagulopathy
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Intensive and perioperative care. Skåne University Hospital. Lund
Lund, Skåne County, 22185
Skåne University Hospital
Lund, Skåne County, 22185
About this study
Official title: Effect of Vitamin K in Critically Ill Patients With Spontaneously Increased Pro-thrombin Time Measured With Routine Coagulation Tests and Advanced Coagulation- and Vitamin K-assays
Critically ill patients with spontaneously prolonged pro-thrombin time, where administration of intravenous administration of phytomenadione (vitamin K) has been ordered by the treating physician will be identified. After signed informed consent baseline samples will be collected. Phytomenadione will be given and 24 hours after administration new blood samples will be collected. Several different advanced coagulation and vitamin K-assays will be performed before and 24 hours after vitamin K administration.
Read the detailed description
Vitamin K-deficiency is common in the peri-operative and intensive care setting. It is often seen in patients with prolonged prothrombin complex (PK-INR). A prolonged (PK-INR) is sometimes treated with intravenous vitamin K, even in non-warfarin treated or non-liver failure patients. Despite the development of this practice the knowledge about how intravenously given vitamin K affects routine coagulation status and other advanced laboratory coagulations assays is rare.
The aim of this study is to investigate the effects of intravenously administered vitamin K on routine coagulation status and on advanced coagulation and vitamin K-assays in post-operative- and critically ill patients with prolonged PK-INR.
Patients with spontaneously prolonged PK-INR are routinely given intravenous vitamin K but it is largely unknown how this procedure affects the included coagulation assays. This research project may contribute to increased knowledge concerning effects of intravenously given vitamin K in critical ill patients with spontaneous coagulopathies. Since spontaneous coagulopathy is frequently occurring in critically ill and postoperative patients due to various underlying conditions and current evidence for vitamin K administration is based on scarce evidence more research in this area is motivated.
- Being tested
- Phytomenadione
- Medical subject headings
- Disseminated Intravascular Coagulation, Vitamin K Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytomenadioneDrug
Blood samples will be taken before and after intravenously prescribed phytomenadione is given. Phytomenadione will be given independently of this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with increased PK-INR | Critically ill patients with spontaneously increased prothrombin complex (PK-INR) who are given phytomenadione intravenously at the discretion of the treating physician Receives: Drug: Phytomenadione |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prothrombin complex (PK-INR)
Prothrombin complex (PK-INR) with Owren and Quick reagents
Measured: Before and 24 hours after given phytomenadione
Secondary outcomes (6)
Change in concentration of coagulation factors II, VII, IX and X in plasma
Measured: Before and 24 hours after given phytomenadione
Change in concentration of PIVKA-II in plasma
Protein Induced by Vitamin K Absence or antagonism for factor II (PIVKA-II)
Measured: Before and 24 hours after given phytomenadione
Change in concentration of protein C and S in plasma
Measured: Before and 24 hours after given phytomenadione
Change in concentration of dp-ucMGP in plasma
Dephospho-uncarboxylated Matrix Gla Protein (dp-ucMGP)
Measured: Before and 24 hours after given phytomenadione
Change in thrombin generation assay in plasma
Measured: Before and 24 hours after given phytomenadione
Change in thromboelastometry assay in whole blood
Thromboelastometry using ROTEM with tissue factor activation (EXTEM reagent)
Measured: Before and 24 hours after given phytomenadione
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start13 Feb 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Factor DeficiencyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kander, Region Skane
- Investigators
- Thomas Kander, Ass. Prof., Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782025
- Sponsor's protocol ID
- VITAKOAG
- Acronym
- VITAKOAG
- Status last verified
- Mar 2021
- First submitted
- 18 Dec 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin K in Critically Ill Patients With Spontaneously Increased Pro-thrombin Time Measured With Routine Coagulation Tests and Advanced Coagulation- and Vitamin K-assays
- ClinicalTrials.gov ID
- NCT03782025
- Acronym / sponsor ID
- VITAKOAG / VITAKOAG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 20 Dec 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.
Critically ill patients with spontaneously prolonged pro-thrombin time, where administration of intravenous administration of phytomenadione (vitamin K) has been ordered by the treating physician will be identified. After signed informed consent baseline samples will be collected. Phytomenadione will be given and 24 hours after administration new blood samples will be collected. Several different advanced coagulation and vitamin K-assays will be performed before and 24 hours after vitamin K administration.
Detailed description
Vitamin K-deficiency is common in the peri-operative and intensive care setting. It is often seen in patients with prolonged prothrombin complex (PK-INR). A prolonged (PK-INR) is sometimes treated with intravenous vitamin K, even in non-warfarin treated or non-liver failure patients. Despite the development of this practice the knowledge about how intravenously given vitamin K affects routine coagulation status and other advanced laboratory coagulations assays is rare.
The aim of this study is to investigate the effects of intravenously administered vitamin K on routine coagulation status and on advanced coagulation and vitamin K-assays in post-operative- and critically ill patients with prolonged PK-INR.
Patients with spontaneously prolonged PK-INR are routinely given intravenous vitamin K but it is largely unknown how this procedure affects the included coagulation assays. This research project may contribute to increased knowledge concerning effects of intravenously given vitamin K in critical ill patients with spontaneous coagulopathies. Since spontaneous coagulopathy is frequently occurring in critically ill and postoperative patients due to various underlying conditions and current evidence for vitamin K administration is based on scarce evidence more research in this area is motivated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with increased PK-INR | – | Drug: PhytomenadioneCritically ill patients with spontaneously increased prothrombin complex (PK-INR) who are given phytomenadione intravenously at the discretion of the treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients at the postoperative care unit or at the intensive care unit with a prothrombin complex (PK-INR) > 1.2 during office hours who are ordered parenteral phytomenadione 10 mg will be eligible for inclusion
Key inclusion criteria (1 listed)
- Critically ill patients at the postoperative care unit or at the intensive care unit with a prothrombin complex (PK-INR) > 1.2 during office hours who are ordered parenteral phytomenadione 10 mg will be eligible for inclusion
Key exclusion criteria (5 listed)
- Warfarin treatment
- Treatment with novel oral anticoagulants
- Hepatocellular carcinoma
- Liver resection within 6 months
- Known pre-existing coagulopathy
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 |
|---|---|---|
| PhytomenadioneBlood samples will be taken before and after intravenously prescribed phytomenadione is given. Phytomenadione will be given independently of this study. | Drug | Patients with increased PK-INR |
Primary outcome
Change in prothrombin complex (PK-INR)
Time frame: Before and 24 hours after given phytomenadione
Prothrombin complex (PK-INR) with Owren and Quick reagents
6 secondary outcomes
Change in concentration of coagulation factors II, VII, IX and X in plasma
Time frame: Before and 24 hours after given phytomenadione
Change in concentration of PIVKA-II in plasma
Time frame: Before and 24 hours after given phytomenadione
Change in concentration of protein C and S in plasma
Time frame: Before and 24 hours after given phytomenadione
Change in concentration of dp-ucMGP in plasma
Time frame: Before and 24 hours after given phytomenadione
Change in thrombin generation assay in plasma
Time frame: Before and 24 hours after given phytomenadione
Change in thromboelastometry assay in whole blood
Time frame: Before and 24 hours after given phytomenadione
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Coagulation Factor Deficiency
RecruitingObservational study
A Database For The Collection Of Clinical, Laboratory, And Treatment Data From Patients With Factor X Deficiency To Define The Natural History Of The Disease And Improve Patient Management
Factor X Deficiency
RecruitingPhase 4
Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
Factor VIII Deficiency
RecruitingPhase 3
Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
Complex Cardiovascular Surgery With Cardiopulmonary Bypass
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
RecruitingObservational study
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Trauma Induced Coagulopathy, Trauma Coagulopathy
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.
Thomas Kander, Ass. Prof. principal investigator
Skane University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Factor Deficiency and Coagulopathy, Consumption, run by Region Skane at 2 sites in Sweden.
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 1 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: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in prothrombin complex (PK-INR) (time frame: Before and 24 hours after given phytomenadione). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.