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首页> 外文期刊>Trials >Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol
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Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol

机译：随机对照试验比较高低低低分子量肝素剂量的疗效和安全性在住院患者严重的Covid-19肺炎和凝血病不需要侵入机械通气（Covid-19 HD）：研究方案的结构化概述

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OBJECTIVES:To assess whether high doses of Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (i.e., Enoxaparin 4000 IU once day), in hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV], are: a)more effective in preventing clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were receiving standard oxygen therapy5.IMV in patients who at randomisation were receiving non-invasive mechanical ventilationb)Similar in terms of major bleeding risk TRIAL DESIGN: Multicentre, randomised controlled, superiority, open label, parallel group, two arms (1:1 ratio), in-hospital study.PARTICIPANTS:Inpatients will be recruited from 7 Italian Academic and non-Academic Internal Medicine Units, 2 Infectious Disease Units and 1 Respiratory Disease Unit.INCLUSION CRITERIA (ALL REQUIRED):1. Age 18 and 80 years 2. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) 3. Severe pneumonia defined by the presence of at least one of the following criteria: a.Respiratory Rate ≥25 breaths /minb.Arterial oxygen saturation≤93% at rest on ambient airc.PaO2/FiO2 ≤300 mmHg 4. Coagulopathy, defined by the presence of at least one of the following criteria: a.D-dimer 4 times the upper level of normal reference rangeb.Sepsis-Induced Coagulopathy (SIC) score 4 5. No need of IMV EXCLUSION CRITERIA: 1. Age 18 and 80 years 2. IMV 3. Thrombocytopenia (platelet count 80.000 mm3) 4. Coagulopathy: INR 1.5, aPTT ratio 1.4 5. Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation 30 ml/min) 6. Known hypersensitivity to enoxaparin 7. History of heparin induced thrombocytopenia 8. Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant cancer at high risk of haemorrhage, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations) 9. Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves) 10. Concomitant double antiplatelet therapy 11. Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed 12. Pregnancy or breastfeeding or positive pregnancy test 13. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition) 14. Lack or withdrawal of informed consent INTERVENTION AND COMPARATOR: Control Group (Low-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa?) at standard prophylactic dose (i.e., 4000 UI subcutaneously once day). Intervention Group (High-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa?) at dose of 70 IU/kg every 12 hours, as reported in the following table. This dose is commonly used in Italy when a bridging strategy is required for the management of surgery or invasive procedures in patients taking anti-vitamin K oral anticoagulants Body Weight (kg)Enoxaparin dose every 12 hours (IU)50200050-69400070-89600090-110800011010000 The treatment with Enoxaparin will be initiated soon after randomization (maximum allowed starting time 12h after randomization). The treatment will be administered every 12 hours in the intervention group and every 24 hours in the control group. Treatments will be administered in the two arms until hospital discharge or the primary outcomes detailed below occur.MAIN OUTCOMES:Primary Efficacy Endpoint: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were in standard oxygen therapy by delivery interfaces5.Need for IMV, in patients who at randomisation were in Cpap or NIV Time to the occurrence of each of these events will be recorded. Clinical worsening will be analysed as a binary outcome as well as a time-to-event one. Secondary Efficacy Endpoints: Any of the following events occurring within the hospital stay 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisati
机译：目标：评估高剂量的低分子量肝素（LMWH）（即每日两次脑诺诺拉林70 IU / kg），与标准预防剂量（即烯脱开草4000 IU一次），在住院的Covid19患者中不需要侵入机械通气[IMV]是：a）在预防临床恶化方面更有效，定义为以下事件中的至少一种，以先到的是：1.death2.Cutute心肌梗死[AMI] 3.药物确认，症状性的动脉或静脉血栓栓塞[TE] 4.无论如何：A. ANCONIONULION阳性气道压力（CPAP）或无侵入式通风（NIV）ORB.IMV，随机化的患者接受随机化患者的标准氧治疗5.imV无侵入机械通风口）在重大出血风险试验设计方面类似：多期，随机控制，优势，开放标签，平行组，两臂（1：1比率），在医院学习.Participants：住院患者将从7个意大利学术和非学术内科，2个传染病单位和1个呼吸道疾病单位招聘。克来标准（全部要求）：1。年龄> 18岁和<80年2.阳性SARS-COV-2诊断（关于深气道的咽部拭子）3.严重的肺炎通过以下至少一个标准存在定义：A.Respiatory率≥25呼吸/ MinB.ARERIAL氧饱和静脉静脉静止静脉静脉静脉静止.Pao2 /FiO2≤300mmHg4.凝结病，通过以下标准中的至少存在定义：Ad-Dimer>正常参考范围的上层的4倍.Sepsis诱导的凝血病（SiC）得分> 4 5.不需要IMV排除标准：1。年龄<18和> 80年2. IMV 3.血小板减少（血小板计数<80.000mm3）4。凝结病：INR> 1.5， APTT比例> 1.4 5.肾功能受损（EGFR通过CKD-EPI肌酸酐型等式的<30mL / min计算）6.已知对烯脱蒿素的超敏反应7.肝素诱导血小板减少症的病史8.存在活性出血或病理易感性易感性在抗凝血存在（例如近期出血性中风，消化性溃疡，恶性癌症高风险出血，最近的神经外科或眼科手术，血管动脉瘤，动脉瘤畸形）9。伴随抗凝血治疗其他适应症（例如心房颤动，静脉血栓栓塞，假性心脏瓣膜）10。伴随着双抗血小板治疗11.在随机化之前，将治疗剂量的LMWH，FONDAPARINOUX或未分支肝素（UFH）施用超过72小时;允许预防剂量12.妊娠或母乳喂养或阳性妊娠试验13.存在其他严重疾病的存在损害预期寿命（例如，鉴于其预先存在的医疗条件，预计患者预计患者未能存活28天）14。缺乏或撤回知情同意干预和比较剂：对照组（低剂量LMWH）：该组的患者将在标准预防剂量（即，每天皮下皮下4000 ui）施用脑诺蛋白（Inixa？）。干预组（高剂量LMWH）：本组中的患者将在下表中报道每12小时以70 IU / kg的剂量给予Enoxaparin（Inixa？）。当抗维生素K口服抗凝剂患者的手术或侵入程序管理需要备用手术或侵袭程序时，这种剂量通常用于意大利，每12小时（IU）每12小时（IU）<50200050-69400070-89600090- 1108000> 11010000将在随机化后立即启动烯脱蒿素的处理（随机化后的最大允许的开始时间12小时）。治疗将在干预组中每12小时施用每12小时，每24小时在对照组中。治疗将在两只武器中施用，直到医院出院或下面详述的主要结果。初级疗效终点：临床恶化，定义为至少一个事件的发生，以先到的方式：1.death2。急性心肌梗死[ami] 3.在随机化的患者中，无论是：a，症状的动脉或静脉血栓栓塞[te] 4.无限性正气道压力（CPAP）或无侵入式通风（NIV）ORB.IMV通过递送腹部进行标准氧疗法5.eed for IMV，在随机化的患者中，将记录每个事件的CPAP或NIV时间，将记录每个事件的发生。将分析临床恶化作为二元结果以及事件时间。次要疗效终点：在医院停留内发生以下事件1.Death2.Acute心肌梗死[AMI] 3.药物证实，症状性动脉或静脉血栓栓塞[TE] 4.无论是：A. Conulous阳性气道压力（ CPAP）或无侵入式通风（NIV）ORB.IMV在Quancisati的患者中

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