NCT04623177.

Study name	Thromboprophylaxis for patients in ICU With COVID‐19
Starting date	1 March 2020
Contact information	Raquel Ferrandis, MD Hospital Universitario La Fe, Valencia, Spain phone and email not available
Methods	Prospective cohort, non‐randomised, open‐label, 3 parallel and comparative arms
Participants	950 participants, ≥ 18 years, female and male Inclusion criteria Confirmed SARS‐CoV‐2 infection from a respiratory tract sample using a PCR assay Admitted to ICU Exclusion criteria Non‐confirmed SARS‐CoV‐2 infection No data at first day ICU admission Patient with do‐not‐resuscitate orders A patient who did not meet the outcomes of death or ICU discharge by the time of study completion date
Interventions	Experimental: anticoagulant dose (≥ 150 IU/kg/24 h) of LMWH within the first 48 h after the ICU admission Experimental: prophylactic dose (lower than 150 IU/kg/24 h) of LMWH within the first 48 h after the ICU admission Comparator: no anticoagulant drug within the first 48 h after the ICU admission
Outcomes	Primary ICU mortality rate (time frame: from admission to ICU discharge, an average of 1 month) Secondary ICU incidence of thrombotic events (time frame: from admission to ICU discharge, an average of 1 month). A composite endpoint to evaluate efficacy made up of myocardial infarction, stroke, incidental PE, PE with worsening of hypoxaemia, PE with haemodynamic repercussion, other venous thromboses without PE ICU incidence of bleeding events (time frame: from admission to ICU discharge, an average of 1 month). Composite endpoint to evaluate safety made up of bleeding needing a transfusion, bleeding with haemodynamic repercussion, another bleeding (minor bleeding) Length of ICU stay (time frame: from admission to ICU discharge, an average of 1 month). Days admitted in ICU Length of invasive mechanical ventilation (time frame: from admission to ICU discharge, an average of 1 month). Days treated with invasive mechanical ventilation (controlled or assisted) Effect of LMWH in other parameters (time frame: from admission to ICU discharge, an average of 1 month). Description of the relationship if any between the use of LMWH and thrombotic or inflammatory parameters (D‐dimer levels, ferritin) or lung dead space
Notes	NCT04623177 | No data provided