Effect of Vitamin K in Critically Ill Patients

Vitamin K Deficiency Clinical Trial

— VITAKOAG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782025
• Other study ID #: VITAKOAG
• Status: Completed
• Start date: February 13, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: March 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coagulation Factor Deficiency
• Coagulopathy, Consumption
• Disseminated Intravascular Coagulation
• Vitamin K Deficiency

Intervention

Drug:
• Phytomenadione
Blood samples will be taken before and after intravenously prescribed phytomenadione is given. Phytomenadione will be given independently of this study.

Locations

Country	Name	City	State
Sweden	Intensive and perioperative care. Skåne University Hospital. Lund	Lund	Skåne
Sweden	Skåne University Hospital	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in prothrombin complex (PK-INR)	Prothrombin complex (PK-INR) with Owren and Quick reagents	Before and 24 hours after given phytomenadione
Secondary	Change in concentration of coagulation factors II, VII, IX and X in plasma		Before and 24 hours after given phytomenadione
Secondary	Change in concentration of PIVKA-II in plasma	Protein Induced by Vitamin K Absence or antagonism for factor II (PIVKA-II)	Before and 24 hours after given phytomenadione
Secondary	Change in concentration of protein C and S in plasma		Before and 24 hours after given phytomenadione
Secondary	Change in concentration of dp-ucMGP in plasma	Dephospho-uncarboxylated Matrix Gla Protein (dp-ucMGP)	Before and 24 hours after given phytomenadione
Secondary	Change in thrombin generation assay in plasma		Before and 24 hours after given phytomenadione
Secondary	Change in thromboelastometry assay in whole blood	Thromboelastometry using ROTEM with tissue factor activation (EXTEM reagent)	Before and 24 hours after given phytomenadione