Official Title
Effectiveness of Thromboprophylaxis With Low Molecular Weight Heparin in Critically Ill Patients With COVID-19. A Prospective, Cohort, Multicenter Study.
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.

Completed
COVID19
Anticoagulant Therapy
Thrombosis
Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

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 Universitario Rio Ortega
Valladolid, Castilla Y León, Spain

Hospital Clinic Barcelona
Barcelona, Cataluña, 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

Hospital Unversitario A Coruña
A Coruña, Galicia, Spain

Complexo Hospitalario Universitario de Ferrol
A Coruña, Galicia, Spain

Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Galicia, Spain

Hospital Povisa
Pontevedra, Galicia, Spain

Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas, Gran Canaria, Spain

Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain

Clínica Universidad de Navarra
Pamplona, Navarra, Spain

Hospital Universitario de Araba
Álava, País Vasco, Spain

Hospital del Mar
Barcelona, Spain

Hospital Sanitas Cima
Barcelona, Spain

Hospital Sant Joan Despí
Barcelona, Spain

Hospital Universitario La Princesa
Madrid, Spain

Hospital Universitario Infanta Leonor
Madrid, Spain

Hospital Clínico San Carlos
Madrid, Spain

Hospital Universitario La Paz
Madrid, Spain

Hospital Universitario Infanta Sofia
Madrid, Spain

Hospital Rafael Méndez
Murcia, Spain

Hospital Clínico Universitario de Valencia
Valencia, Spain

Hospital Arnau de Vilanova
Valencia, Spain

Hospital Universitario Doctor Peset
Valencia, Spain

Hospital Universitari La Fe
Valencia, Spain

Raquel Ferrandis, MD, Study Chair
Hospital Universitario La Fe

Instituto de Investigacion Sanitaria La Fe
NCT Number
Keywords
COVID19
Low Molecular Weight Heparin
Thromboprophylaxis
Anticoagulant treatment
thrombosis
MeSH Terms
COVID-19
Thrombosis