Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- low molecular weight heparin (enoxaparin) and mortality rate
研究概览
简要总结
Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms. Multiple pathogenic mechanisms are involved, including endothelial dysfunction, increased von Willebrand factor, Toll receptor activation, and tissue factor pathway activation. D-dimer levels greater than 1000 ng / mL are associated with an 18-fold increased risk of mortality. In this context, many patients may require prophylaxis or antithrombotic treatment with low molecular weight heparins. Currently, there is no validated scheme on the dose and timing of the use of antithrombotic drugs.
The study aims to identify the effect of two anticoagulant strategies (prophylactic and therapeutic) on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care.
详细描述
Randomized clinical trial in patients with a confirmed infection by COVID-19 who require hospital treatment and subsequent ambulatory surveillance.
Study population. Patients with a diagnosis by PCR of COVID 19, over 18 years of age from the High Specialty Hospital of Ixtapaluca, who meet the inclusion criteria.
Statistic analysis. The student's T-test was carried out to identify the difference in the means of the quantitative variables between the groups. A value of P ≤ 0.05, 95% CI will be considered significant. For the hypothesis test, the chi-square test will be performed, considering a p≤ 0.05, 95% CI value to be significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of COVID-19 infection confirmed by polymerase chain reaction test (RQ-PCR) requiring hospital care for the administration of supplemental oxygen
排除标准
- •Patients with life expectancy less than 48hrs
- •Patients who require ventilatory support upon admission
- •Age over 75 years or with a history of atrial fibrillation
- •History of venous or arterial thrombosis
- •Severe neurological impairment
- •Absence of a primary caregiver to supervise the administration of medication
- •History of cerebral hemorrhage
- •History of previous use of oral anticoagulants
- •History of major surgery 30 days prior to admission
- •Uncontrolled systemic arterial hypertension
- •KDIGO stage III chronic kidney disease or less
- •Hemodialysis or peritoneal dialysis treatment
- •History of active or inactive cancer
- •Pregnant or postpartum patients
研究组 & 干预措施
Prophylactic enexaparin
Enoxaparin dose of 1mg / kg / dose twice daily
干预措施: Enoxaparin (Drug)
Therapeutic Enoxaparin
Enoxaparin dose of 1mg / kg / dose daily
干预措施: Enoxaparin (Drug)
结局指标
主要结局
low molecular weight heparin (enoxaparin) and mortality rate
时间窗: 30 days
Identify the benefit of different doses of low molecular weight heparin (enoxaparin) over mortality rate in patients requiring hospital care for COVID-19 infection.
low molecular weight heparin (enoxaparin) and ventilatory support time
时间窗: 30 days
Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on ventilatory support time in patients requiring hospital care for COVID-19 infection.
thrombotic complications and Rivaroxaban
时间窗: 30 days
To compare oral anticoagulation therapy by administering Rivaroxaban 10mg PO every 24 hours on early thrombotic complications
low molecular weight heparin (enoxaparin) and length of hospital stay
时间窗: 30 days
Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the length of hospital stay in patients requiring hospital care for COVID-19 infection.
次要结局
未报告次要终点
研究者
Omar Ramos-Peñafiel
Principal Investigator
Hospital Regional de Alta especialidad de Ixtapaluca