COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 16
- 主要终点
- Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization
研究概览
简要总结
The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth to <18 years of age; AND
- •Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
- •Hospitalized, <72 hours post-admission; AND
- •One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as follows:
- •Fever (oral temperature >100.4°F/38°C); OR
- •Chest pain; OR
- •Shortness of breath; OR
- •Myalgia; OR
- •Acute unexplained loss of smell or taste; OR
- •New/increased supplemental oxygen requirement; OR
- •Acute respiratory failure requiring non-invasive or invasive ventilation; OR
- •Encephalitis.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; OR
- •Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past 72 hours; OR
- •Platelet count <50,000/µL within the past 24 hours; OR
- •Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
- •Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
- •Fibrinogen level <75 mg/dL; OR
- •Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) <31 mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR
- •Parent or legally authorized representative unwilling to provide informed consent for patient participation.
研究组 & 干预措施
Thromboprophylaxis
Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
干预措施: Enoxaparin Prefilled Syringe [Lovenox] (Drug)
结局指标
主要结局
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization
时间窗: Day 30
The safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis will be measured by cumulative incidence (number of participants) of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1. fatal bleeding; 2. clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3. retroperitoneal, pulmonary, or central nervous system bleeding; 4. bleeding requiring surgical intervention in an operating suite; 5. bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6. bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
次要结局
- Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL(4 hours post initial dose)