COVID-19-associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID-19
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
This prospective, randomized, open-label, multi-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).
详细描述
Potentially eligible patients will be identified by a healthcare professional per institutional policy on privacy. The healthcare professional will assess the eligibility of the patient by performing a chart review which will include laboratory results and weight as measured on admission to the hospital. After obtaining verbal consent from the patient to be contacted for the study, a member of the research staff will approach the patient to be part of the study. The research staff will obtain informed consent from the patient/LAR before collecting any data and performing any procedures.
5.2 Trial interventions
As standard of care, hospitalized patients with confirmed COVID-19 will be monitored for coagulopathy. Daily blood tests for platelet count, prothrombin time, D-Dimer, and fibrinogen and weekly thromboelastography will be obtained, and a daily Modified ISTH Overt DIC score will be calculated (Exhibit 1). Only patients meeting all inclusion and exclusion criteria will be asked to participate in the trial. Patients will be randomized to one of two arms:
- Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI <30 kg/m2; 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30 kg/m2).
- Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI <30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30 kg/m2), with doses rounded up to the nearest dose syringe in hospitalized patients with laboratory confirmed SARS CoV-2 infection.
5.3 Dose Modifications
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laboratory confirmed SARS-CoV-2 infection
- •Age ≥18 years
- •Requires hospital admission for further clinical management
- •Modified ISTH Overt DIC score ≥ 3
排除标准
- •Indication for full therapeutic-dose anticoagulation
- •Acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior 3 months
- •Acute cardiovascular event within prior 3 months
- •Acute stroke (ischemic or hemorrhagic) within prior 3 months
- •Active major bleeding
- •Severe thrombocytopenia (<25,000/mm3)
- •Increased risk of bleeding, as assessed by the investigator
- •Acute or chronic renal insufficiency with Creatinine Clearance < 30 ml/min calculated by the modified Cockcroft and Gault formula
- •Weight < 40 kg
- •Known allergies to ingredients contained in enoxaparin, allergy to heparin products or history of heparin induced thrombocytopenia
研究组 & 干预措施
Standard of Care
- Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI <30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
干预措施: Standard of Care thromboprophylaxis (Drug)
Interventional
- Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
干预措施: Intermediate dose thromboprophylaxis (Drug)
结局指标
主要结局
Mortality
时间窗: 30 Days post intervention
All-cause mortality
次要结局
- Number of Participants With Acute Kidney Injury(30 days post intervention)
- Number of Participants With Arterial Thrombosis(30 Days post intervention)
- Number of Participants With Major Bleeding(30 Days post intervention)
- Number of Participants With Venous Thrombosis(30 Days post intervention)
- Number of Participants With Minor Bleeding(30 Days post intervention)
研究者
Usha Perepu
Sponser Investigator
University of Iowa