Effect of Vitamin K in Critically Ill Patients

Completed

• Conditions: Vitamin K Deficiency; Coagulopathy, Consumption; Coagulation Factor Deficiency
• Interventions: Drug: Phytomenadione

• Registration Number: NCT03782025
• Lead Sponsor: Region Skane

Brief 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.

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 Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Study Start: 2019-02-13
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with increased PK-INR	Phytomenadione	Critically ill patients with spontaneously increased prothrombin complex (PK-INR) who are given phytomenadione intravenously at the discretion of the treating physician

Primary Outcome Measures

Name	Time	Method
Change in prothrombin complex (PK-INR)	Before and 24 hours after given phytomenadione	Prothrombin complex (PK-INR) with Owren and Quick reagents

Secondary Outcome Measures

Name	Time	Method
Change in concentration of PIVKA-II in plasma	Before and 24 hours after given phytomenadione	Protein Induced by Vitamin K Absence or antagonism for factor II (PIVKA-II)
Change in concentration of protein C and S in plasma	Before and 24 hours after given phytomenadione
Change in thromboelastometry assay in whole blood	Before and 24 hours after given phytomenadione	Thromboelastometry using ROTEM with tissue factor activation (EXTEM reagent)
Change in concentration of coagulation factors II, VII, IX and X in plasma	Before and 24 hours after given phytomenadione
Change in concentration of dp-ucMGP in plasma	Before and 24 hours after given phytomenadione	Dephospho-uncarboxylated Matrix Gla Protein (dp-ucMGP)
Change in thrombin generation assay in plasma	Before and 24 hours after given phytomenadione

Trial Locations

Locations (2)

Skåne University Hospital; 🇸🇪 Lund, Skåne, Sweden

Intensive and perioperative care. Skåne University Hospital. Lund; 🇸🇪 Lund, Skåne, Sweden