Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Coronary Artery Bypass Vein Graft Patency
研究概览
简要总结
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with a negative antibody result will also be followed in the study. All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts. This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts.
详细描述
This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers will serve as a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 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
- •Patients scheduled for CABG (males or non-pregnant females)
- •> 18 years old with at least one vein graft planned
- •Able to provide written informed consent
排除标准
- •Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status
- •Documented history of allergy to iodinated contrast media, warfarin, or argatroban
- •Chronic renal impairment with CrCl<60 ml/min
- •Recent bleeding episode
- •Congestive Heart Failure (EF< 30%)
- •Bleeding diathesis or known thrombophilic disorder
- •Atrial fibrillation or other condition requiring anticoagulation at the time of enrollment
- •Documented history of heparin induced thrombocytopenia
- •Clinical suspicion of HIT at the time of randomization, defined as 50% decrease in Platelet count from last heparin exposure or Platelet count <100,000/ml
- •Hepatic dysfunction (defined as LFTs > 3 times the upper limit of normal)
- •Patients with a history of bleeding complications post-CABG
- •Hemorrhagic stroke
- •Gastrointestinal bleeding
- •Requirement for fresh frozen plasma
- •Recent central nervous system or ophthalmic surgery
- •History of psychosis or senility
- •Malignant hypertension
- •Clinically significant pericarditis or pericardial effusion
- •Bacterial endocarditis
- •Hematocrit < 24%
- •Valve replacement or repair at time of CABG
- •Subjects with signs or symptoms of possible Transient Ischemic Attack or stroke
研究组 & 干预措施
Heparin PF4 antibody positive -Drug (argatroban and warfarin)
Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
干预措施: Argatroban and warfarin (Drug)
结局指标
主要结局
Coronary Artery Bypass Vein Graft Patency
时间窗: Approximately 30 Days post CABG
Vein graft patency as measured by computed tomography
次要结局
- Major Bleeding Events.(At 2weeks post CABG)
研究者
Ik-Kyung Jang, MD, PhD
Professor of Medicine
Massachusetts General Hospital