Thromboprophylaxis for Patients in ICU With COVID-19
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|ClinicalTrials.gov Identifier: NCT04623177|
Recruitment Status : Active, not recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
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.
|Condition or disease|
|Covid19 Anticoagulant Therapy Thrombosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||950 participants|
|Official Title:||Effectiveness of Thromboprophylaxis With Low Molecular Weight Heparin in Critically Ill Patients With COVID-19. A Prospective, Cohort, Multicenter Study.|
|Actual Study Start Date :||March 1, 2020|
|Actual Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||November 2020|
Patients receiving an anticoagulant dose (equal or higher than 150 IU/kg/24 h) of LMWH within the first 48 hours after the ICU admission
Patients receiving a prophylactic dose (lower than 150 IU/kg/24 h) of LMWH within the first 48 hours after the ICU admission
Patients receiving no anticoagulant drug within the first 48 hours after the ICU admission
- ICU mortality [ Time Frame: From admission to ICU discharge, an average of 1 month ]Rate of mortality
- 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 pulmonary thromboembolism, pulmonary thromboembolism with worsening of hypoxemia, Pulmonary thromboembolism with hemodynamic repercussion, other venous thromboses without pulmonary thromboembolism
- 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 transfusion, bleeding wit hemodynamic repercussion, other 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623177
|Study Chair:||Raquel Ferrandis, MD||Hospital Universitario La Fe|