Clinical trial NCT04623177: Thromboprophylaxis for Patients in ICU With COVID-19
Official title: Effectiveness of Thromboprophylaxis With Low Molecular Weight Heparin in Critically Ill Patients With COVID-19. A Prospective, Cohort, Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Anticoagulant Therapy
Thrombosis
Keywords: Covid19
Low Molecular weight heparin
Thromboprophylaxis
Anticoagulant treatment
Thrombosis
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Doctor Peset
name: Hospital Clinic of Barcelona
name: Hospital Universitario La Paz
name: Hospital Universitario La Fe
name: Hospital de Sant Joan Despí Moisès Broggi
name: University of Navarrra Hospital (Clinica Universitaria)
name: Hospital de Cruces
First posted: 2020-11-10
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive COVID-19 patients admitted to participating ICUs from March 12th to September 1st were included if they fulfill the inclusion criteria and present no exclusion criteria

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.

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

Primary outcomes:
measure: ICU mortality
timeFrame: From admission to ICU discharge, an average of 1 month
Secondary outcomes:
measure: ICU incidence of thrombotic events
timeFrame: From admission to ICU discharge, an average of 1 month
measure: ICU incidence of bleeding events
timeFrame: From admission to ICU discharge, an average of 1 month
measure: Length of ICU stay
timeFrame: From admission to ICU discharge, an average of 1 month
measure: Length of invasive mechanical ventilation
timeFrame: From admission to ICU discharge, an average of 1 month
measure: Effect of LMWH in other parameters
timeFrame: From admission to ICU discharge, an average of 1 month
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
state: Aragón
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
state: Castilla La Mancha
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
state: Castilla Y León
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Ortega
state: Castilla Y León
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de Terrasa
state: Cataluña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Comunidad Valenciana
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
state: Comunidad Valenciana
city: Cáceres
country: Spain
facility: Complejo Hospitalario de Cáceres
state: Extramedura
city: A Coruña
country: Spain
facility: Hospital Unversitario A Coruña
state: Galicia
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de Ferrol
state: Galicia
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
state: Galicia
city: Pontevedra
country: Spain
facility: Hospital Povisa
state: Galicia
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrín
state: Gran Canaria
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Álava
country: Spain
facility: Hospital Universitario de Araba
state: País Vasco
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Sanitas Cima
city: Barcelona
country: Spain
facility: Hospital Sant Joan Despí
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofia
city: Murcia
country: Spain
facility: Hospital Rafael Méndez
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitari La Fe
Study officials:
affiliation: Hospital Universitario La Fe
name: Raquel Ferrandis, MD
role: STUDY_CHAIR
References:
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