Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial

AbstractObjectivesTo assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation.Trial designThis is a single centre parallel group, superiority, randomized (1:1 allocation ratio) controlled trial.ParticipantsAll patients admitted to the Hamad Medical Corporation -ICU in Qatar for COVID-19 associated respiratory distress and in need of mechanical ventilation are screened for eligibility.Inclusion criteria: all adult patients admitted to the ICU who test positive for COVID-19 by PCR-test and in need for mechanical ventilation are eligible for inclusion. Upon crossing the limit of D-dimers (1.2 mg/L) these patients are routinely treated with an increased dose of anticoagulant according to our local protocol. This will be the start of randomization.Exclusion criteria: pregnancy, allergic to the drug, inherited coagulation abnormalities, no informed consent.Intervention and comparatorThe intervention group will receive the anticoagulant bivalirudin intravenously with a target aPTT of 45-70 sec for three days while the control group will stay on the standard treatment with low-molecular-weight heparins /unfractionated heparin subcutaneously (see scheme in Additional file1).All other treatment will be unchanged and left to the attending physicians.Main outcomesAs a surrogate parameter for clinical improvement and primary outcome we will use the PaO2/FiO2 (P/F...
Source: Trials - Category: Research Source Type: clinical trials