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Completed

NCT Number: NCT04623177

Thromboprophylaxis for Patients in ICU With COVID-19

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.

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Key information

Conditions

Covid19 Anticoagulant Therapy COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombosis Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universitario Lozano Blesa, Zaragoza, Aragon, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ICU mortality

    Time frame: From admission to ICU discharge, an average of 1 month

    Rate of mortality

Secondary outcomes

  1. 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

  2. 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)

  3. Length of ICU stay

    Time frame: From admission to ICU discharge, an average of 1 month

    Days admitted in ICU

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Hospital Universitario Doctor Peset
  • Hospital Universitario La Fe
  • Hospital Universitario La Paz
  • Hospital de Cruces
  • Hospital de Sant Joan Despí Moisès Broggi
  • University of Navarrra Hospital (Clinica Universitaria)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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