Optimizing the Diagnosis of Heparin Induced Thrombocytopenia Using Quantified Anti-Platelet Factor 4 Immunological Testing: A Pilot Multicentre Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
Multicentre (Ottawa and Halifax) prospective cohort study using a diagnostic approach in patients clinically suspected to have HIT that combines pretest probability assessment with quantitative interpretation of anti-PF4 assay.
详细描述
The proposed is a prospective cohort study exploring a novel diagnostic approach to Heparin Induced Thrombocytopenia (HIT) using a combination of pretest probability assessment and quantitative interpretation of the anti-platelet factor 4 Immunological assay (anti-PF4). Patient with a clinical suspicion of HIT will follow the study diagnostic algorithm (Figure 1). The study algorithm will be considered a safe approach to move forward into a larger RCT if the upper limit of the 95% confidence interval for 'false negative management failures' is ≤ 4% based on a Serotonin Release Assay (SRA) gold standard. The main objective of the pilot study is to inform feasibility and recruitment barriers for a larger randomized control trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with clinical suspicion of HIT by treating physician
排除标准
- •Less than 18 years of age;
- •Prior diagnosis of HIT ever;
- •Patient enrolled within preceding 100 days;
- •Functional/ confirmatory platelet activation results available at the time of enrollment;
- •Requiring cardio-pulmonary bypass or percutaneous cardiac angioplasty or any other cardiac or vascular surgery/procedure requiring intra-operative/procedural heparin administration planned within 30 days;
- •Unable to complete study follow up;
- •Unable to obtain consent (or proxy consent from substitute decision maker where applicable);
- •Life expectancy less than 30 days;
- •Greater than 72 hours from clinical suspicion of HIT and/or request for HIT anti-PF4 ELISA testing.
结局指标
主要结局
Recruitment
时间窗: 2 years
The pilot will be considered feasible if recruitment of at least 7.5 patients per month (total between the two sites) is achieved.
False negative management failures
时间窗: 2 years
The rate of false negative 'management failures' where the study protocol concludes HIT unlikely but SRA (reference standard laboratory test) is positive for HIT (≥50% Serotonin release).
次要结局
- Death(30 days of follow up)
- Major arterial and venous thromboembolism events(24 hours of baseline and 24 of study enrolment)
- Proximal deep vein thrombosis(2 years)
- Pulmonary embolism(2 years)
- Stroke(2 years)
- Myocardial infarction(2 years)
- Systemic arterial embolism(2 years)