Anticoagulant Therapy, Covid19, Thrombosis
Conditions
Keywords
Covid19, Low Molecular weight heparin, Thromboprophylaxis, Anticoagulant treatment, Thrombosis
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.
Interventions
None listed
Sponsors
Hospital Universitario Doctor Peset
Hospital Clinic of Barcelona
Hospital Universitario La Paz
Hospital Universitario La Fe
Hospital de Sant Joan Despí Moisès Broggi
University of Navarrra Hospital (Clinica Universitaria)
Hospital de Cruces
Instituto de Investigacion Sanitaria La Fe
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed SARS-CoV2 infection from a respiratory tract sample using a polymerase chain reaction assay. * Admitted to ICU
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | From admission to ICU discharge, an average of 1 month | Rate of mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 ICU stay | From admission to ICU discharge, an average of 1 month | Days admitted in ICU |
| Length of invasive mechanical ventilation | 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 | 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 |
Countries
Spain
Outcome results
None listed