Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •laboratory confirmed positive test for SARS-CoV-2
- •admitted to ICU because of respiratory failure caused by Covid-19
排除标准
- •patients with treatment for thromboembolic complications at arrival to the ICU
- •short ICU length of stay defined as discharged the same date as ICU admission
- •patients without initial thromboprophylaxis
研究组 & 干预措施
low dose thromboprophylaxis
Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin
干预措施: Dose of tinzaparin or dalteparin (Drug)
medium dose thromboprophylaxis
Daily dose of >4500 IU but <175 IU/kg of body weight tinzaparin or >5000 IU but <200 IU/kg of body weight dalteparin
干预措施: Dose of tinzaparin or dalteparin (Drug)
high dose thromboprophylaxis
Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin
干预措施: Dose of tinzaparin or dalteparin (Drug)
结局指标
主要结局
28-day mortality
时间窗: 28 days from ICU-admission
28-day mortality from admission to ICU. Discontinue of ICU-care to palliative care counts as death.
次要结局
- Incidence of thromboembolic events(28 days from ICU-admission)
- Incidence of bleeding events(28 days from ICU-admission)
- ICU-free days alive from ICU-admission(28 days from ICU-admission)
- 90-day mortality(90 days from ICU-admission)
研究者
Sandra Jonmarker
Principal investigator, MD, PhD-student
Karolinska Institutet