The effect of administering VITamin K preprocedural on the vitamin K dependent coagulation factors and the INR in patients anticoagulated with ACEnocoumarol

The effect of administering VITamin K preprocedural on the vitamin K dependent coagulation factors and the INR in patients anticoagulated with ACEnocoumarol - VITKACE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002291-41-NL

Enrollment

Registered

2018-08-30

Start date

2018-08-30

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

Adult patients using acenocoumarol and planned to undergo an invasive procedure for which the effect of the anticoagulants should be reversed.

Interventions

Trade Name: Vitamin K Pharmaceutical Form: INN or Proposed INN: Fytomenadion Other descriptive name: VITAMIN K Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients on acenocoumarol requiring an invasive procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Age < 18 years. - Patients requiring periprocedural bridging therapy according to our local protocol based on national guidelines with low-molecular-weight-heparin (LMWH). - Inherited or acquired coagulopathies. - Inability or incompetency to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify which coagulation factors are involved in inadequate INR normalization after vitamin K administration 36-48 hours prior to invasive procedures in patients that continue acenocoumarol perioperatively.;Secondary Objective: - To assess the proportion of patients reaching target INR <1.8 at the day of the invasive procedure after the local procedure at ZGV. - To assess the number of patients experiencing either thromboembolic or bleeding complications after the administration of 10 mg vitamin K. - To assess the time between the invasive procedure and recovery of the INR to a therapeutic level after the local procedure. - To store a whole blood sample from each patient for pharmacogenetics analyses, which can be used to correlate the change in coagulation factors to.;Primary end point(s): Prothrombin and factor VII activity at the day of the invasive procedure.;Timepoint(s) of evaluation of this end point: Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure.	—

Measure

Time frame

Main Objective: To identify which coagulation factors are involved in inadequate INR normalization after vitamin K administration 36-48 hours prior to invasive procedures in patients that continue acenocoumarol perioperatively.;Secondary Objective: - To assess the proportion of patients reaching target INR <1.8 at the day of the invasive procedure after the local procedure at ZGV. - To assess the number of patients experiencing either thromboembolic or bleeding complications after the administration of 10 mg vitamin K. - To assess the time between the invasive procedure and recovery of the INR to a therapeutic level after the local procedure. - To store a whole blood sample from each patient for pharmacogenetics analyses, which can be used to correlate the change in coagulation factors to.;Primary end point(s): Prothrombin and factor VII activity at the day of the invasive procedure.;Timepoint(s) of evaluation of this end point: Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure.

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Secondary

Measure	Time frame
Secondary end point(s): - The number of patients with an INR <1.8 just prior to the invasive procedure. - Number of thromboembolic or bleeding events occurring within 30 days after the intervention. According to the International Society of Thrombosis and Haemostatis (ISTH) guidelines bleeding complications are defined as major if they are fatal, symptomatic bleeding intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and / or lead to fall In hemoglobin of 1.24 mmol/L or more, or leading to a blood transfusion of two or more units of whole blood or red cells.9 Also, thromboembolic events (such as deep venous thrombosis, TIA/stroke, peripheral embolism) are recorded. - Time to achieve therapeutic INR in acenocoumarol users who are administered a single dose of vitamin K 36-48 hours before the invasive procedure.;Timepoint(s) of evaluation of this end point: Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure.	—

Measure

Time frame

Secondary end point(s): - The number of patients with an INR <1.8 just prior to the invasive procedure. - Number of thromboembolic or bleeding events occurring within 30 days after the intervention. According to the International Society of Thrombosis and Haemostatis (ISTH) guidelines bleeding complications are defined as major if they are fatal, symptomatic bleeding intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and / or lead to fall In hemoglobin of 1.24 mmol/L or more, or leading to a blood transfusion of two or more units of whole blood or red cells.9 Also, thromboembolic events (such as deep venous thrombosis, TIA/stroke, peripheral embolism) are recorded. - Time to achieve therapeutic INR in acenocoumarol users who are administered a single dose of vitamin K 36-48 hours before the invasive procedure.;Timepoint(s) of evaluation of this end point: Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure.

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Countries

Netherlands

Contacts

Public Contactdr. R. Bemelmans

Gelderse Vallei Hospital

00310318434343

Outcome results

None listed

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