Skip to main content
OpenTrials
Completed

NCT Number: NCT03782025

Effect of Vitamin K in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive and perioperative care. Skåne University Hospital. Lund, Lund, Skåne County, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phytomenadione

Drug

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

Primary outcomes

  1. Change in prothrombin complex (PK-INR)

    Time frame: Before and 24 hours after given phytomenadione

    Prothrombin complex (PK-INR) with Owren and Quick reagents

Secondary outcomes

  1. Change in concentration of coagulation factors II, VII, IX and X in plasma

    Time frame: Before and 24 hours after given phytomenadione

  2. Change in concentration of PIVKA-II in plasma

    Time frame: Before and 24 hours after given phytomenadione

    Protein Induced by Vitamin K Absence or antagonism for factor II (PIVKA-II)

  3. Change in concentration of protein C and S in plasma

    Time frame: Before and 24 hours after given phytomenadione

  4. Change in concentration of dp-ucMGP in plasma

    Time frame: Before and 24 hours after given phytomenadione

    Dephospho-uncarboxylated Matrix Gla Protein (dp-ucMGP)

  5. Change in thrombin generation assay in plasma

    Time frame: Before and 24 hours after given phytomenadione

  6. Change in thromboelastometry assay in whole blood

    Time frame: Before and 24 hours after given phytomenadione

    Thromboelastometry using ROTEM with tissue factor activation (EXTEM reagent)

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study 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

Acronym: VITAKOAG

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.