A Study to Evaluate AntiThrombotic Therapy to Lessen Complications of COVID-19 (Enrolling by Invitation Only)

Overview

Información sobre este estudio

The purpose of this study is to establish whether therapeutic-dose parenteral anticoagulation improves outcomes (reduces intubation or mortality) by 30 days after randomization.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • Willing and able to provide (possibly through a substitute decision maker) informed consent.
  • Require hospitalization anticipated to last ≥ 72 hours for microbiologically-confirmed COVID-19.
  • Enrolled < 72 hours of hospital admission or of COVID-19 confirmation.

Exclusion Criteria:

  • Patients < 18 years of age.
  • Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization.
  • Patients for whom the intent is to not use pharmacologic thromboprophylaxis.
  • Active bleeding.
  • Risk factors for bleeding, including:
    • intracranial surgery or stroke within 3 months;
    • history of intracerebral arteriovenous malformation;
    • cerebral aneurysm or mass lesions of the central nervous system;
    • intracranial malignancy;
    • history of intracranial bleeding;
    • history of bleeding diatheses (e.g., hemophilia);
    • history of gastrointestinal bleeding within previous 3 months;
    • thrombolysis within the previous 7 days;
    • presence of an epidural or spinal catheter;
    • recent major surgery 200 mmHg, dBP > 120 mmHg);
    • other physician-perceived contraindications to anticoagulation.
  • Platelet count 2.0, or baseline aPTT > 50.
  • Hemoglobin < 80 g/L (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur).
  • Acute or subacute bacterial endocarditis.
  • History of heparin induced thrombocytopenia (HIT) or other heparin allergy including hypersensitivity.
  • Current use of dual antiplatelet therapy.
  • Patients with an independent indication for therapeutic anticoagulation.
  • Patients in whom imminent demise is anticipated and there is no commitment to active ongoing intervention.
  • Anticipated transfer to another hospital that is not a study site within 72 hours.
  • Enrollment in other trials related to anti-coagulation or antiplatelet therapy

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Vivek Iyer, M.D., M.P.H.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20502364

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