Thromboprophylaxis for Patients in ICU With COVID-19

Sponsor
Instituto de Investigacion Sanitaria La Fe (Other)
Overall Status
Active, not recruiting
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)
950
Enrollment
31
Locations
8
Anticipated Duration (Months)
30.6
Patients Per Site
3.8
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 DiseaseIntervention/TreatmentPhase

    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
    Anticipated Enrollment :
    950 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
    Anticipated Study Completion Date :
    Nov 1, 2020

    Arms and Interventions

    ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Hospital Clínico Universitario Lozano BlesaZaragozaAragónSpain50009
    2Hospital General de Ciudad RealCiudad RealCastilla La ManchaSpain13005
    3Complejo Asistencial Universitario de LeónLeónCastilla Y LeónSpain24080
    4Hospital Universitario Rio OrtegaValladolidCastilla Y LeónSpain47012
    5Hospital Clinic BarcelonaBarcelonaCataluñaSpain08036
    6Hospital de la Santa Creu i Sant PauBarcelonaCataluñaSpain8041
    7Hospital de TerrasaBarcelonaCataluñaSpain8227
    8Hospital General Universitario de AlicanteAlicanteComunidad ValencianaSpain3010
    9Hospital Universitario San Juan de AlicanteAlicanteComunidad ValencianaSpain3550
    10Complejo Hospitalario de CáceresCáceresExtrameduraSpain10003
    11Hospital Unversitario A CoruñaA CoruñaGaliciaSpain15006
    12Complexo Hospitalario Universitario de FerrolA CoruñaGaliciaSpain15405
    13Complexo Hospitalario Universitario de PontevedraPontevedraGaliciaSpain36071
    14Hospital PovisaPontevedraGaliciaSpain36211
    15Hospital Universitario de Gran Canaria Dr. NegrínLas PalmasGran CanariaSpain35010
    16Hospital Universitario Severo OchoaLeganésMadridSpain28911
    17Clínica Universidad de NavarraPamplonaNavarraSpain31008
    18Hospital Universitario de ArabaÁlavaPaís VascoSpain1009
    19Hospital del MarBarcelonaSpain8003
    20Hospital Sanitas CimaBarcelonaSpain8034
    21Hospital Sant Joan DespíBarcelonaSpain8970
    22Hospital Universitario La PrincesaMadridSpain28006
    23Hospital Universitario Infanta LeonorMadridSpain28031
    24Hospital Clínico San CarlosMadridSpain28040
    25Hospital Universitario La PazMadridSpain28046
    26Hospital Universitario Infanta SofiaMadridSpain28702
    27Hospital Rafael MéndezMurciaSpain30817
    28Hospital Clínico Universitario de ValenciaValenciaSpain46010
    29Hospital Arnau de VilanovaValenciaSpain46015
    30Hospital Universitario Doctor PesetValenciaSpain46017
    31Hospital Universitari La FeValenciaSpain46026

    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:
    Nov 10, 2020
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2020