Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study (HIT-RADIO Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 668
- 试验地点
- 21
- 主要终点
- Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis
研究概览
简要总结
HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse information that is already in the patients' medical records. Information about laboratory values (such as platelet counts), treatments (such as medications), and outcomes (such as blood clots, amputation, and death) will be included.
详细描述
HIT-RADIO is a retrospective chart-review study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals associated with the Transfusion Medicine/Hemostasis Clinical Trials Network .
Heparin-induced thrombocytopenia (HIT) is a major complication of the administration of heparin and can result in life-threatening thrombosis with or without thrombocytopenia (HIT-T) or can produce thrombocytopenia without clinically symptomatic thrombosis ("isolated" HIT). Isolated heparin-induced thrombocytopenia is defined as a fall in platelet count associated with a positive heparin PF-4 antibody test, in the absence of clinically overt thrombosis. While the treatment of HIT-T (HIT with thrombosis) with anticoagulation is well established, the risks and treatment of isolated HIT are unclear.
It is anticipated that this data analysis will provide a current overview of the implications of a positive heparin PF-4 antibody test in clinical practice. It should determine the percentage of positive heparin PF-4 antibody tests that are associated with thrombocytopenia and thrombosis (HIT-T) or "isolated" HIT at diagnosis and the subsequent major clinical outcomes of death, limb amputation/gangrene, and new thrombosis. No "snapshot" of such HIT patients has been conducted in the past decade and the results will be important in assessing the impact of HIT in current medical care as well as documenting current treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects with a positive heparin PF-4 antibody test occurring between 1/21/2008 and 9/25/2008
- •Medical record available for the admission during which the positive heparin PF-4 antibody test was obtained
排除标准
- 未提供
结局指标
主要结局
Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis
时间窗: From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.
The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis.
次要结局
- Time to Death(From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Time to Occurrence of Limb Amputation or Limb Gangrene(From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Time to Occurrence of Radiographically Confirmed Thromboembolism(From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Time to Occurrence of Major Bleeding(From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT(From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn)
- Type of Heparin Exposure - Unfractionated Heparin (UFH)(Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn)
- Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)(Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn)
- Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis(From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia(From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint(From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Use of Treatment (Non-heparin Anticoagulant) Used in Hospital(From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge(From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first)
- Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn(From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first)