EFFECTIVNESS OF WARFARIN REVERSAL USING INTRAVENOUS VITAMIN K AMONG HIP FRACTURE OLDER PERSONS: A RANDOMIZED CLINICAL TRIAL

EFFECTIVNESS OF WARFARIN REVERSAL USING INTRAVENOUS VITAMIN K AMONG HIP FRACTURE OLDER PERSONS: A RANDOMIZED CLINICAL TRIAL - VK-WIFE STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002354-20-IT

Enrollment

Registered

2021-06-08

Start date

2016-09-14

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fractured subjects on warfarin therapy MedDRA version: 23.0 Level: PT Classification code 10020100 Term: Hip fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: KONAKION - 10MG/ML SOLUZIONE ORALE E INIETTABILE 3 FIALE DA 1 ML Product Name: Fitomenadione Pharmaceutical Form: Solution for infusion INN or Proposed INN: FITOMENADIONE Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -subject, male and female, aged 65 years or older with a diagnosis of hip fracture with indication for surgical treatment; -subject taking warfarin; -subject willing and able to give written informed consent for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62

Exclusion criteria

Exclusion criteria: - subject with multiple trauma fractures; -subjects with mechanical heart valves or venous thromboebolism within 3 months or thrombophilia; - subject with hypersensivity to Phytonadion or to any of its excipients; - subject with severe hepatic failure; - any other condition that, in the clinical judgment of the investigator, means that it would not be in the best interests of the subject to enter the study; - subject currently enrolled in other trial; - subject unwilling or unable to give the informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate, in comparison with usual care practice, the efficacy of an established pharmacological reversal approach with Phytonadione (vitamin K1) on reducing time to decrease INR until the safe cut off value recommended for surgery in hip fractured patients taking warfarin.;Secondary Objective: -to evaluate, in comparison with usual care practice, the proportion of patients in the intervention group who undergo surgery within 48 hours or the length of stay less than 7 days between the two groups; -to evaluate safety of doses and route of vitamin K established by our protocol in terms of thromboembolic events and in-hospital mortality; -to evaluate safety of doses and route of vitamin K established by our protocol in terms of adverse drug reactions. ;Primary end point(s): The primary outcome will be assessed by the difference in the proportion of persons who reach the safe cut off for the INR within 24 hours. ;Timepoint(s) of evaluation of this end point: 24 hours	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate, in comparison with usual care practice, the efficacy of an established pharmacological reversal approach with Phytonadione (vitamin K1) on reducing time to decrease INR until the safe cut off value recommended for surgery in hip fractured patients taking warfarin.;Secondary Objective: -to evaluate, in comparison with usual care practice, the proportion of patients in the intervention group who undergo surgery within 48 hours or the length of stay less than 7 days between the two groups; -to evaluate safety of doses and route of vitamin K established by our protocol in terms of thromboembolic events and in-hospital mortality; -to evaluate safety of doses and route of vitamin K established by our protocol in terms of adverse drug reactions. ;Primary end point(s): The primary outcome will be assessed by the difference in the proportion of persons who reach the safe cut off for the INR within 24 hours. ;Timepoint(s) of evaluation of this end point: 24 hours

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Secondary

Measure	Time frame
Secondary end point(s): The secondary outcomes are difference in the proportion of: - number of patients who undergo surgery within 48 hours and number of patient with an hospital stay less than 7 days; - cases with thromboembolic events and in-hospital mortality; - cases with allergic or anaphylactic reactions after administration of vitamin K. ;Timepoint(s) of evaluation of this end point: in hospital stay	—

Measure

Time frame

Secondary end point(s): The secondary outcomes are difference in the proportion of: - number of patients who undergo surgery within 48 hours and number of patient with an hospital stay less than 7 days; - cases with thromboembolic events and in-hospital mortality; - cases with allergic or anaphylactic reactions after administration of vitamin K. ;Timepoint(s) of evaluation of this end point: in hospital stay

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Countries

Italy

Contacts

Public ContactSez di Gerontologia Geriatria - Dip

Sez di Gerontologia Geriatria - Dip di Medicina - Universit¿ di Perugia

carmelinda.ruggiero@unipg.it0755783839

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026