Thromboprophylaxis for Patients in ICU With COVID-19
- Conditions
- ThrombosisCovid19Anticoagulant Therapy
- Registration Number
- NCT04623177
- Lead Sponsor
- Instituto de Investigacion Sanitaria La Fe
- Brief Summary
The respiratory distress that goes with COVID-19 infection has been related to a procoagulant state, with thrombosis at both venous and arterial levels, that determines hypoxia and tissue dysfunction at several organs. The main sign of this thrombotic activity seems to be the D-Dimers, that have been proposed to identify patients with poor prognosis at an early stage.
Knowledge on how to prevent or even treat this procoagulant state is scarce. COVID-19 patients may be out of general thromboprophylaxis recommendations, and recent studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with low molecular weight heparin (LMWH). However, the LMWH efficacy and safety, mainly in patients admitted to an Intensive Care Unit, remains to be validated.
- Detailed Description
Many reports have postulated a procoagulant state along with the respiratory distress caused by coronavirus SARS-CoV2. A complex physiopathology has been proposed trying to explain this profile, mainly based on the thromboinflammatory concept, with thrombosis at both venous and arterial levels. Microvascular thrombi impair the blood flow all over the body, with a vascular shunt due to capillary obstruction, that determines hypoxia and tissue dysfunction at several organs, being the lung the more affected one.
Although D-Dimers (DD) are not specific indicators of clot formation, its elevation, in combination with other parameters (hyperfibrinogenemia, mild thrombocytopenia) may suggest a systemic coagulation activation with an increase of thrombin generation and fibrinolysis. In fact, in a retrospective Chinese analysis, a DD higher than 1000 ng/ml was proposed to identify patients with poor prognosis at an early stage.
Nevertheless, knowledge on how to prevent or even treat this procoagulant state is scarce. Thromboprophylaxis with low molecular-weight heparin (LMWH) is recommended in most medical patients admitted to the hospital and in nearly all patients in an Intensive Care Unit (ICU). But COVID-19 patients may be out of these recommendations, and some treatment schemes has been proposed, although how to decide the suitable LMWH for each clinical situation is controversial. Recent retrospective studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with LMWH. However, the LMWH efficacy and safety, mainly in COVID-19 patients admitted to the ICU, remains to be validated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 822
- Confirmed SARS-CoV2 infection from a respiratory tract sample using a polymerase chain reaction assay.
- Admitted to ICU
- Non-confirmed SARS-CoV2 infection
- No data at first day ICU admission
- Patient with do-not resuscitate orders
- Patient who did not meet the outcomes of death or ICU discharge by the time of study completion date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICU mortality From admission to ICU discharge, an average of 1 month Rate of mortality
- Secondary Outcome Measures
Name Time Method ICU incidence of thrombotic events From admission to ICU discharge, an average of 1 month A composite endpoint to evaluate efficacy made up of: myocardial infarction, stroke, incidental pulmonary thromboembolism, pulmonary thromboembolism with worsening of hypoxemia, Pulmonary thromboembolism with hemodynamic repercussion, other venous thromboses without pulmonary thromboembolism
Effect of LMWH in other parameters 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
ICU incidence of bleeding events From admission to ICU discharge, an average of 1 month Composite endpoint to evaluate safety made up of: bleeding needing transfusion, bleeding wit hemodynamic repercussion, other bleeding (minor bleeding)
Length of invasive mechanical ventilation From admission to ICU discharge, an average of 1 month Days treated with invasive mechanical ventilation (controlled or assisted)
Length of ICU stay From admission to ICU discharge, an average of 1 month Days admitted in ICU
Trial Locations
- Locations (31)
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Aragón, Spain
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Castilla La Mancha, Spain
Complejo Asistencial Universitario de León
🇪🇸León, Castilla Y León, Spain
Hospital Clinic Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitario Rio Ortega
🇪🇸Valladolid, Castilla Y León, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Hospital de Terrasa
🇪🇸Barcelona, Cataluña, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Comunidad Valenciana, Spain
Hospital Universitario San Juan de Alicante
🇪🇸Alicante, Comunidad Valenciana, Spain
Complejo Hospitalario de Cáceres
🇪🇸Cáceres, Extramedura, Spain
Complexo Hospitalario Universitario de Pontevedra
🇪🇸Pontevedra, Galicia, Spain
Hospital Unversitario A Coruña
🇪🇸A Coruña, Galicia, Spain
Complexo Hospitalario Universitario de Ferrol
🇪🇸A Coruña, Galicia, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
🇪🇸Las Palmas, Gran Canaria, Spain
Hospital Povisa
🇪🇸Pontevedra, Galicia, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Sanitas Cima
🇪🇸Barcelona, Spain
Hospital Sant Joan Despí
🇪🇸Barcelona, Spain
Hospital Universitario de Araba
🇪🇸Álava, País Vasco, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Rafael Méndez
🇪🇸Murcia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitari La Fe
🇪🇸Valencia, Spain
Hospital Universitario Infanta Sofia
🇪🇸Madrid, Spain