NCT04842292终止2 期
Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure
Brittany Bissell1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Mean PaO2/FiO2 Ratio
研究概览
简要总结
The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours
排除标准
- •Allergy to heparin
- •Any history of heparin-induced thrombocytopenia
- •High risk of bleeding (platelet count < 50,000/µL or international normalized ratio > 1.5)
- •Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
- •Active bleeding
- •Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring repeated suctioning, and temporally associated with acute deterioration in respiratory status)
- •Neurosurgical procedures during this hospital admission or such procedures are planned
- •Epidural catheter in place
- •Any history of intracranial, spinal or epidural hemorrhage
- •Tracheostomy in place
- •Cervical spinal cord injury associated with reduced long-term ability to breathe independently
- •Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to breathe independently
- •Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy
- •Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure
- •Death is deemed imminent or inevitable or there is an underlying disease with a life expectancy of fewer than 90 days
- •Pregnant or might be pregnant.
- •Objection from the treating clinician
- •Consent refused by the patient or substitute decision maker.
- •History of thrombosis (VTE or cardiovascular event)
研究组 & 干预措施
Nebulized heparin
Experimental
Nebulized heparin 25,000 units in 3 mL inhalation every 6 hours
干预措施: Heparin (Drug)
Nebulized placebo
Placebo Comparator
Sodium chloride 0.9% 5 mL inhalation every 6 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Mean PaO2/FiO2 Ratio
时间窗: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
次要结局
- Clinically Significant Bleeding(Up to discharge or 3 months following enrollment, whichever occurs first)
- Incidence of Venous Thromboembolism(Up to discharge or 3 months following enrollment, whichever occurs first)
研究者
Brittany Bissell
Assistant Professor
University of Kentucky
研究点 (1)
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