Single-blind, Randomized Comparison of Warfarin Management Guided by NextDose Versus Management Based on Clinician Experience.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 主要终点
- Percentage of Time Within Range
研究概览
简要总结
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 quality of anticoagulation therapy.
Endpoint Primary
- Percentage of time within the acceptable INR range estimated using linear interpolation during the 28 days after initiation of warfarin.
Secondary 2.1 Percentage of Time Measures 2.2 Time to Stable Dose 2.3 Safety Outcomes 2.4 Acceptability of NextDose Recommendations Exploratory 3.1 Percentage of Time Measures 3.2 Time to Stable Dose 3.3 Safety Outcomes 3.4 Acceptability of NextDose Recommendations 3.5 Model Evaluation 3.6 INR Variability
Population:
240 participants of any sex between the age of 18 and 80 years. Patients requiring treatment with warfarin following cardiac surgery.
详细描述
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 quality of anticoagulation therapy.
Endpoint Primary
- Percentage of time within the acceptable INR range estimated using linear interpolation during the 28 days after initiation of warfarin.
Secondary 2.1 Percentage of Time Measures
- Percentage of time within the acceptable INR Range estimated using linear interpolation during the 90 days after initiation of warfarin.
- Percentage of time spent above and below the acceptable INR range at day 28, and 90 after initiation of warfarin estimated by linear interpolation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
All patients who are screened for enrolment will be allocated an enrolment number. The recruiting clinician will record into a logbook the details of all patients screened for enrolment, including the reason for exclusion from trial entry.
A randomization sequence using block randomization with random block sizes of 4, 6 and 8 (to maintain equal sample size in each arm) will be created by researchers using PASS. Assignments will be enclosed in sequentially numbered, opaque, sealed envelopes.
Participants who provide written informed consent and are enrolled will be allocated to study arm by the study pharmacists. The pharmacist will be responsible for opening envelopes sequentially, writing the participant enrollment number on the envelope prior to opening, and recording the envelope number and study arm allocation in the CRF. On conclusion of the data collection phase, the (actual) study allocation status of the participants will be compared to the randomization sequence.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Percentage of Time Within Range
时间窗: 28 days after initiation of warfarin
The percentage of time spent within the acceptable INR range (± 0.5 of target INR) as estimated using linear interpolation during the 28 days after initiation of warfarin.
次要结局
- Number of participants who experience at least one of the following safety events:(60 days of surgery.)
- Percentage of prescribed doses within 0.625 mg of the NextDose proposed dose.(90 days after initiation of warfarin)
- Time to Stable Dose(90 days after initiation of warfarin)
- Mean difference between the prescribed dose and the NextDose proposed dose.(90 days after initiation of warfarin)
- Percentage of Time Measure(day 28, and 90 after initiation of warfarin)
研究者
Miao Liyan
vice-president
The First Affiliated Hospital of Soochow University