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Thromboprophylaxis for Patients in ICU With COVID-19

Sponsor
Instituto de Investigacion Sanitaria La Fe (Other)
Overall Status
Completed
CT.gov ID
NCT04623177
Collaborator
Hospital Universitario Doctor Peset (Other), Hospital Clinic of Barcelona (Other), Hospital Universitario La Paz (Other), Hospital Universitario La Fe (Other), Hospital de Sant Joan Despí Moisès Broggi (Other), University of Navarrra Hospital (Clinica Universitaria) (Other), Hospital Universitario Cruces (Other)
822
Enrollment
31
Locations
9
Actual Duration (Months)
26.5
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    822 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 :
    Mar 1, 2020
    Actual Primary Completion Date :
    Sep 30, 2020
    Actual Study Completion Date :
    Nov 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Anticoagulation

    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
    Thromboprophylaxis

    Patients receiving a prophylactic dose (lower than 150 IU/kg/24 h) of LMWH within the first 48 hours after the ICU admission
    No heparin

    Patients receiving no anticoagulant drug within the first 48 hours after the ICU admission

    Outcome Measures

    Primary Outcome Measures

    1. ICU mortality [From admission to ICU discharge, an average of 1 month]

      Rate of mortality

    Secondary Outcome Measures

    1. 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

    2. 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)

    3. Length of ICU stay [From admission to ICU discharge, an average of 1 month]

      Days admitted in ICU

    4. Length of invasive mechanical ventilation [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clínico Universitario Lozano Blesa Zaragoza Aragón Spain 50009
    2 Hospital General de Ciudad Real Ciudad Real Castilla La Mancha Spain 13005
    3 Complejo Asistencial Universitario de León León Castilla Y León Spain 24080
    4 Hospital Universitario Rio Ortega Valladolid Castilla Y León Spain 47012
    5 Hospital Clinic Barcelona Barcelona Cataluña Spain 08036
    6 Hospital de la Santa Creu i Sant Pau Barcelona Cataluña Spain 8041
    7 Hospital de Terrasa Barcelona Cataluña Spain 8227
    8 Hospital General Universitario de Alicante Alicante Comunidad Valenciana Spain 3010
    9 Hospital Universitario San Juan de Alicante Alicante Comunidad Valenciana Spain 3550
    10 Complejo Hospitalario de Cáceres Cáceres Extramedura Spain 10003
    11 Hospital Unversitario A Coruña A Coruña Galicia Spain 15006
    12 Complexo Hospitalario Universitario de Ferrol A Coruña Galicia Spain 15405
    13 Complexo Hospitalario Universitario de Pontevedra Pontevedra Galicia Spain 36071
    14 Hospital Povisa Pontevedra Galicia Spain 36211
    15 Hospital Universitario de Gran Canaria Dr. Negrín Las Palmas Gran Canaria Spain 35010
    16 Hospital Universitario Severo Ochoa Leganés Madrid Spain 28911
    17 Clínica Universidad de Navarra Pamplona Navarra Spain 31008
    18 Hospital Universitario de Araba Álava País Vasco Spain 1009
    19 Hospital del Mar Barcelona Spain 8003
    20 Hospital Sanitas Cima Barcelona Spain 8034
    21 Hospital Sant Joan Despí Barcelona Spain 8970
    22 Hospital Universitario La Princesa Madrid Spain 28006
    23 Hospital Universitario Infanta Leonor Madrid Spain 28031
    24 Hospital Clínico San Carlos Madrid Spain 28040
    25 Hospital Universitario La Paz Madrid Spain 28046
    26 Hospital Universitario Infanta Sofia Madrid Spain 28702
    27 Hospital Rafael Méndez Murcia Spain 30817
    28 Hospital Clínico Universitario de Valencia Valencia Spain 46010
    29 Hospital Arnau de Vilanova Valencia Spain 46015
    30 Hospital Universitario Doctor Peset Valencia Spain 46017
    31 Hospital Universitari La Fe Valencia Spain 46026

    Sponsors and Collaborators

    • Instituto de Investigacion Sanitaria La Fe
    • 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 Universitario Cruces

    Investigators

    • Study Chair: Raquel Ferrandis, MD, Hospital Universitario La Fe

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Instituto de Investigacion Sanitaria La Fe
    ClinicalTrials.gov Identifier:
    NCT04623177
    Other Study ID Numbers:
    • RegCoVid-19
    First Posted:
    Nov 10, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Instituto de Investigacion Sanitaria La Fe
    Covid19
    Low Molecular weight heparin
    Thromboprophylaxis
    Anticoagulant treatment
    Thrombosis
    Additional relevant MeSH terms:
    COVID-19
    Thrombosis

    Study Results

    No Results Posted as of Mar 31, 2022