Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Time spent under invasive mechanical ventilation
研究概览
简要总结
Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin.
Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators and Outcome assessors will not take part in the care of patients. Data will be provide in anonymous form without any indication to the assigned treatment.
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
- •ratio between arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) < 200 mmHg
- •age equal or greater of 18 years/old
- •detection of coronavirus 2019 at the nasal swab;
- •need for endotracheal intubation and invasive mechanical ventilation
排除标准
- •known allergies to one of the two investigated drugs
- •presence of hematological diseases
- •pregnancy
- •recent (10 days) surgery
- •presence of active bleeding
研究组 & 干预措施
Enoxaparin sodium
Enoxaparin sodium twice daily, according to the renal function and clinical indication
干预措施: Enoxaparin Sodium (Drug)
Bivalirudin
Bivalirudin will be administered by continuous infusion, until day 7. Bivalirudin will be administered at dosage of 0,25 mg/kg in first 30 minutes, followed by continuous infusion of 0,2 mg/kg/h until 7 days. The infusion rate will be adjusted targeting a prothrombin time ratio of about 1.5.
干预措施: Bivalirudin (Drug)
结局指标
主要结局
Time spent under invasive mechanical ventilation
时间窗: from randomization till 28 days after randomization
number of days that patient would require invasive mechanical ventilation
次要结局
- Incidence of vein thrombosis and embolism(from randomization till 28 days after randomization or ICU discharge)
- Intensive Care Unit length of stay(Up to 1 year)
- Intensive Care Unit mortality(Up to 1 year)
- Gas Exchange(Every day till 28 days after randomization or ICU discharge)
研究者
Federico Longhini
Director of the Intensive Care and Anesthesia Department
University Magna Graecia