EUCTR2020-002190-10-IE进行中（未招募）1 期
Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG) - RAPID COVID COAG
niversity College Dublin0 个研究点目标入组 24 人开始时间: 2021年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •4.1.The inclusion criteria are:
- •1)Laboratory confirmed COVID-19 (diagnosis of SARS-CoV-2 via reverse transcriptase polymerase chain reaction as per the World Health Organization protocol or by nucleic acid based isothermal amplification); positive test prior to hospital admission OR within first 5 days (ie 120 hours) after hospital admission
- •2)Admitted to hospital for COVID-19;
- •3)One D-dimer value above ULN (within 5 days (ie 120 hours) of hospital admission) AND EITHER:
- •a.D-Dimer =2 times ULN OR
- •b.D-Dimer above ULN and Oxygen saturation = 93% on room air;
- •4)> 18 years of age;
- •5)Informed consent from the patient (or legally authorized substitute decision maker).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1)pregnancy;
- •2)hemoglobin <80 g/L in the last 72 hours;
- •3)platelet count <50 x 109/L in the last 72 hours;
- •4)known fibrinogen <1.5 g/L (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation);
- •5)known INR >1.8 (if testing deemed clinically indicated by the treating physician prior to the initiation of anticoagulation);
- •6)patient already on intermediate dosing of LMWH that cannot be changed (determination of what constitutes an intermediate dose is to be at the discretion of the treating clinician taking the local institutional thromboprophylaxis protocol for high risk patients into consideration);
- •7)patient already on therapeutic anticoagulation at the time of screening (low or high dose nomogram UFH, LMWH, warfarin, direct oral anticoagulant (any dose of dabigatran, apixaban, rivaroxaban, edoxaban);
- •8)patient on dual antiplatelet therapy, when one of the agents cannot be stopped safely;
- •9)known bleeding within the last 30 days requiring emergency room presentation or hospitalization;
- •10)known history of a bleeding disorder of an inherited or active acquired bleeding disorder;
- •11)known history of heparin-induced thrombocytopenia;
- •12)known allergy to UFH or LMWH;
- •13)admitted to the intensive care unit at the time of screening
- •14) treated with non-invasive positive pressure ventilation or invasive mechanical ventilation at the time of screening (of note: high flow oxygen delivery via nasal cannula is acceptable and is not an exclusion criterion);
- •15)Imminent death according to the judgement of the most responsible physician;
- •16)enrollment in another clinical trial of antithrombotic therapy involving pre-intensive care unit hospitalized patients.
研究者
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