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Treatment-Dose LMWH versus Prophylactic/Intermediate Dose Heparins in High-Risk COVID-19 Inpatients: Rationale and Design of the HEP-COVID Trial.
Goldin, Mark; Giannis, Dimitrios; Diab, Wassim; Wang, Janice; Khanijo, Sameer; Sharifova, Gulru; Cohen, Marc; Lund, Jeet M; Mignatti, Andrea; Gianos, Eugenia; Tafur, Alfonso; Lewis, Paul A; Cohoon, Kevin; Kittelson, John M; Lesser, Martin L; Sison, Cristina P; Rahman, Husneara; Ochani, Kanta; Hiatt, William R; Dale, Rita A; Anderson, Victoria E; Bonaca, Marc; Halperin, Jonathan L; Weitz, Jeffrey I; Spyropoulos, Alex C.
Afiliação
  • Goldin M; Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.
  • Giannis D; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Diab W; Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.
  • Wang J; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Khanijo S; Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.
  • Sharifova G; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Cohen M; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Lund JM; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Mignatti A; Department of Medicine, Newark Beth Israel Medical Center, Newark, New Jersey, United States.
  • Gianos E; Wellspan York Hospital, York, Pennsylvania, United States.
  • Tafur A; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Lewis PA; Department of Cardiology, Lenox Hill Hospital, Northwell Health, New York, New York, United States.
  • Cohoon K; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Kittelson JM; Department of Cardiology, Lenox Hill Hospital, Northwell Health, New York, New York, United States.
  • Lesser ML; Department of Medicine and Vascular Medicine, NorthShore University Health System, Evanston, Illinois, United States.
  • Sison CP; Division of Cardiology, University of Chicago, Pritzker School of Medicine, Chicago, Illinois, United States.
  • Rahman H; Evidence Based Medicine, Baycare Health System, Clearwater, Florida, United States.
  • Ochani K; Division of Cardiovascular Medicine, Department of Medicine, Froedtert and Medical College of Wisconsin, Milwaukee, Wisconsin, United States.
  • Hiatt WR; Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.
  • Dale RA; Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.
  • Anderson VE; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Bonaca M; Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.
  • Halperin JL; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, United States.
  • Weitz JI; Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.
  • Spyropoulos AC; Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, United States.
Thromb Haemost ; 121(12): 1684-1695, 2021 12.
Article em En | MEDLINE | ID: mdl-33823560
Coronavirus disease-2019 (COVID-19) has been associated with significant risk of venous thromboembolism (VTE), arterial thromboembolism (ATE), and mortality particularly among hospitalized patients with critical illness and elevated D-dimer (Dd) levels. Conflicting data have yet to elucidate optimal thromboprophylaxis dosing. HEP-COVID (NCT04401293) is a phase 3, multicenter, pragmatic, prospective, randomized, pseudo-blinded, active control trial to evaluate efficacy and safety of therapeutic-dose low-molecular-weight heparin (LMWH) versus prophylactic-/intermediate-dose LMWH or unfractionated heparin (UFH) for prevention of a primary efficacy composite outcome of VTE, ATE, and all-cause mortality 30 ± 2 days post-enrollment. Eligible patients have COVID-19 diagnosis by nasal swab or serologic testing, requirement for supplemental oxygen per investigator judgment, and Dd >4 × upper limit of normal (ULN) or sepsis-induced coagulopathy score ≥4. Subjects are randomized to enoxaparin 1 mg/kg subcutaneous (SQ)/two times a day (BID) (creatinine clearance [CrCl] ≥ 30 mL/min) or 0.5 mg/kg (CrCl 15-30 mL/min) versus local institutional prophylactic regimens including (1) UFH up to 22,500 IU (international unit) daily (divided BID or three times a day), (2) enoxaparin 30 and 40 mg SQ QD (once daily) or BID, or (3) dalteparin 2,500 IU or 5,000 IU QD. The principal safety outcome is major bleeding. Events are adjudicated locally. Based on expected 40% relative risk reduction with treatment-dose compared with prophylactic-dose prophylaxis, 308 subjects will be enrolled (assuming 20% drop-out) to achieve 80% power. Distinguishing design features include an enriched population for the composite endpoint anchored on Dd >4 × ULN, stratification by intensive care unit (ICU) versus non-ICU, and the ability to capture asymptomatic proximal deep venous thrombosis via screening ultrasonography prior to discharge.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tromboembolia / Enoxaparina / Tratamento Farmacológico da COVID-19 / Anticoagulantes Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tromboembolia / Enoxaparina / Tratamento Farmacológico da COVID-19 / Anticoagulantes Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article