Effect of Vitamin K in Critically Ill Patients

NCT03782025 | Completed

• 1 other identifier: VITAKOAG
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Coagulation Factor Deficiency; Coagulopathy, Consumption; Vitamin K Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in prothrombin complex (PK-INR)

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

  Before and 24 hours after given phytomenadione

Secondary Outcomes (6)

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

  Before and 24 hours after given phytomenadione

• Change in concentration of PIVKA-II in plasma

  Before and 24 hours after given phytomenadione

• Change in concentration of protein C and S in plasma

  Before and 24 hours after given phytomenadione

• Change in concentration of dp-ucMGP in plasma

  Before and 24 hours after given phytomenadione

• Change in thrombin generation assay in plasma

  Before and 24 hours after given phytomenadione

Study Arms (1)

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

Drug: Phytomenadione

Interventions

Phytomenadione DRUG

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

Patients with increased PK-INR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may not qualify if:

• Warfarin treatment
• Treatment with novel oral anticoagulants
• Hepatocellular carcinoma
• Liver resection within 6 months
• Known pre-existing coagulopathy

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Intensive and perioperative care. Skåne University Hospital. Lund

Lund, Skåne County, 22185, Sweden

Location

Skåne University Hospital

Lund, Skåne County, 22185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be centrifuged and stored in -80 degrees C in anticipation of batch analysis of coagulation factor- and vitamin K-analyses. There will be no DNA analysis. All blood samples will be destroyed after the mentioned analyses.

MeSH Terms

Conditions

Disseminated Intravascular Coagulation; Vitamin K Deficiency

Interventions

Vitamin K 1

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Thomas Kander, Ass. Prof.

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: February 13, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)