|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 March 2021 |
|
Main ID: |
NCT03782025 |
|
Date of registration:
|
18/12/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Vitamin K in Critically Ill Patients
VITAKOAG |
|
Scientific 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 |
|
Date of first enrolment:
|
February 13, 2019 |
|
Target sample size:
|
52 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03782025 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Sweden
| | | | | | | |
|
Contacts
|
|
Name:
|
Thomas Kander, Ass. Prof. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Skane University Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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
Exclusion Criteria:
- Warfarin treatment
- Treatment with novel oral anticoagulants
- Hepatocellular carcinoma
- Liver resection within 6 months
- Known pre-existing coagulopathy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Coagulation Factor Deficiency
|
|
Coagulopathy, Consumption
|
|
Vitamin K Deficiency
|
|
Intervention(s)
|
|
Drug: Phytomenadione
|
|
Primary Outcome(s)
|
|
Change in prothrombin complex (PK-INR)
[Time Frame: Before and 24 hours after given phytomenadione]
|
|
Secondary Outcome(s)
|
|
Change in concentration of PIVKA-II 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 concentration of protein C and S 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 concentration of coagulation factors II, VII, IX and X 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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|