Status:
UNKNOWN
Effectiveness of NextDose for Warfarin Dose Individualization
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Thrombosis Embolism
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Objectives: To understand whether the implementation of warfarin dose management using NextDose (nextdose.org) at The First Affiliated Hospital of Soochow University (Suzhou, China) improves the qual...
Detailed Description
Objectives: To understand whether the implementation of warfarin dose management using NextDose (nextdose.org) at The First Affiliated Hospital of Soochow University (Suzhou, China) improves the qual...
Eligibility Criteria
Inclusion
- Scheduled to undergo cardiac surgery with planned warfarin anticoagulation for at least three months.
- Age ≥ 18 and \< 80 years.
- Written informed consent has been obtained.
Exclusion
- Allergy to warfarin tablet or excipients.
- Enrollment or planned enrollment in other research that would conflict with full participation in the study or confound the observation or interpretation of the study findings.
- Patients who in the opinion of the recruiting clinician are:
- unwilling or unable to comply with the protocol requirements and/or,
- considered unreliable concerning the requirements for follow-up during the study and/or, compliance with drug administration.
- Patient with life expectancy less than the expected duration of the trial due to concomitant disease.
- Contraindication to warfarin therapy. The following are examples but not an exhaustive list:
- Pregnancy.
- Cerebral infarction or cerebral haemorrhage (from patients' medical record) within the 3 months prior to heart valve replacement
- Severe heart failure (New York Heart Function Class IV)
- Severe renal failure (CLcr (Cockcroft-Gault) ≤20mL / min)
- Severe liver failure (Child-Pugh≥10)
- Abnormal liver function (elevated transaminase more than three times the upper limit of the local hospital clinical laboratory).
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04510805
Start Date
August 1 2020
End Date
December 1 2021
Last Update
August 19 2020
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