Efficacy of Oral Vitamin K to reverse chronic Warfarin Anticoagulation at 24 hours: A Phase 2 pharmacological Modelling Study.

Phase 2

Recruiting

• Conditions: Anticoagulation; Blood - Clotting disorders

• Registration Number: ACTRN12612000665831
• Lead Sponsor: Dr Noel Chan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients aged 18 years and older, capable of giving informed consent, who are receiving warfarin for the treatment of VTE and who are about to end anticoagulation or temporarily cease anticoagulation as they are deemed to be at low risk of thrombo-embolic recurrence.

Exclusion Criteria

Any indications for the need for ongoing anticoagulation or high thromboembolic risk patients (e.g: AF, antiphospholipid syndrome, recurrent idiopathic VTE , Stroke or TIA).
Fat malabsorption syndromes, biliary atresia, pancreatic insufficiency.
Allergic reaction to Vitamin K and coconut oil.
Unstable INR, or recent INR<2, or INR>4
Pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The lowest effective dose of oral Vitamin K (Neokay) that is capable of at least 95% reversal of an INR to <1.5 at 24 hours following oral administation derived from a non linear, mixed effects population PK-PD pharmacological model.[T=24 hours]