tetano
Editor, Senior Moderator
J Thromb Haemost
. 2020 Sep 5.
doi: 10.1111/jth.15094. Online ahead of print.
Anticoagulant interventions in hospitalized patients with COVID-19: A scoping review of randomized controlled trials and call for international collaboration
Tobias Tritschler[SUP] 1 2 [/SUP], Marie-Eve Mathieu[SUP] 1 [/SUP], Leslie Skeith[SUP] 3 [/SUP], Marc Rodger[SUP] 4 [/SUP], Saskia Middeldorp[SUP] 5 [/SUP], Timothy Brighton[SUP] 6 [/SUP], Per Morten Sandset[SUP] 7 [/SUP], Susan R Kahn[SUP] 4 8 [/SUP], Derek C Angus[SUP] 9 [/SUP], Marc Blondon[SUP] 10 [/SUP], Marc J Bonten[SUP] 11 [/SUP], Marco Cattaneo[SUP] 12 [/SUP], Mary Cushman[SUP] 13 [/SUP], Lennie P G Derde[SUP] 11 14 [/SUP], Maria T DeSancho[SUP] 15 [/SUP], Jean-Luc Diehl[SUP] 16 17 [/SUP], Ewan Goligher[SUP] 18 19 [/SUP], Bernd Jilma[SUP] 20 [/SUP], Peter J?ni[SUP] 21 22 [/SUP], Patrick R Lawler[SUP] 23 24 25 [/SUP], Marco Marietta[SUP] 26 [/SUP], John C Marshall[SUP] 27 [/SUP], Colin McArthur[SUP] 28 [/SUP], Carlos Henrique Miranda[SUP] 29 [/SUP], Tristan Mirault[SUP] 17 30 31 [/SUP], Nuccia Morici[SUP] 32 [/SUP], Usha Perepu[SUP] 33 [/SUP], Christian Sch?rgenhofer[SUP] 20 [/SUP], Michelle Sholzberg[SUP] 34 [/SUP], Alex C Spyropoulos[SUP] 35 [/SUP], Steve A Webb[SUP] 36 [/SUP], Ryan Zarychanski[SUP] 37 38 [/SUP], St?phane Zuily[SUP] 39 [/SUP], Gr?goire Le Gal[SUP] 1 [/SUP], International Network of VENous Thromboembolism Clinical Research Networks INVENT-VTE
Affiliations
Abstract
Introduction: Coronavirus disease (COVID-19) is associated with a high incidence of thrombosis and mortality despite standard anticoagulant thromboprophylaxis. There is equipoise regarding the optimal dose of anticoagulant intervention in hospitalized patients with COVID-19 and consequently, immediate answers from high-quality randomized trials are needed.
Methods: The World Health Organization's International Clinical Trials Registry Platform was searched on June 17, 2020 for randomized controlled trials comparing increased dose to standard dose anticoagulant interventions in hospitalized COVID-19 patients. Two authors independently screened the full records for eligibility and extracted data in duplicate.
Results: A total of 20 trials were included in the review. All trials are open-label, 5 trials use an adaptive design, 1 trial uses a factorial design, 2 trials combine multi-arm parallel group and factorial designs in flexible platform trials, and at least 15 trials have multiple study sites. With individual target sample sizes ranging from 30 to 3,000 participants, the pooled sample size of all included trials is 12,568 participants. Two trials include only ICU patients, and 10 trials base patient eligibility on elevated D-dimer levels. Therapeutic intensity anticoagulation is evaluated in 14 trials. All-cause mortality is part of the primary outcome in 14 trials.
Discussion: Several trials evaluate different dose regimens of anticoagulant interventions in hospitalized patients with COVID-19. Since these trials compete for sites and study participants, a collaborative effort is needed to complete trials faster, conduct pooled analyses and bring effective interventions to patients more quickly.
Keywords: Anticoagulant; COVID-19; Pulmonary Embolism; Research Networks; Thrombosis.
. 2020 Sep 5.
doi: 10.1111/jth.15094. Online ahead of print.
Anticoagulant interventions in hospitalized patients with COVID-19: A scoping review of randomized controlled trials and call for international collaboration
Tobias Tritschler[SUP] 1 2 [/SUP], Marie-Eve Mathieu[SUP] 1 [/SUP], Leslie Skeith[SUP] 3 [/SUP], Marc Rodger[SUP] 4 [/SUP], Saskia Middeldorp[SUP] 5 [/SUP], Timothy Brighton[SUP] 6 [/SUP], Per Morten Sandset[SUP] 7 [/SUP], Susan R Kahn[SUP] 4 8 [/SUP], Derek C Angus[SUP] 9 [/SUP], Marc Blondon[SUP] 10 [/SUP], Marc J Bonten[SUP] 11 [/SUP], Marco Cattaneo[SUP] 12 [/SUP], Mary Cushman[SUP] 13 [/SUP], Lennie P G Derde[SUP] 11 14 [/SUP], Maria T DeSancho[SUP] 15 [/SUP], Jean-Luc Diehl[SUP] 16 17 [/SUP], Ewan Goligher[SUP] 18 19 [/SUP], Bernd Jilma[SUP] 20 [/SUP], Peter J?ni[SUP] 21 22 [/SUP], Patrick R Lawler[SUP] 23 24 25 [/SUP], Marco Marietta[SUP] 26 [/SUP], John C Marshall[SUP] 27 [/SUP], Colin McArthur[SUP] 28 [/SUP], Carlos Henrique Miranda[SUP] 29 [/SUP], Tristan Mirault[SUP] 17 30 31 [/SUP], Nuccia Morici[SUP] 32 [/SUP], Usha Perepu[SUP] 33 [/SUP], Christian Sch?rgenhofer[SUP] 20 [/SUP], Michelle Sholzberg[SUP] 34 [/SUP], Alex C Spyropoulos[SUP] 35 [/SUP], Steve A Webb[SUP] 36 [/SUP], Ryan Zarychanski[SUP] 37 38 [/SUP], St?phane Zuily[SUP] 39 [/SUP], Gr?goire Le Gal[SUP] 1 [/SUP], International Network of VENous Thromboembolism Clinical Research Networks INVENT-VTE
Affiliations
- PMID: 32888372
- DOI: 10.1111/jth.15094
Abstract
Introduction: Coronavirus disease (COVID-19) is associated with a high incidence of thrombosis and mortality despite standard anticoagulant thromboprophylaxis. There is equipoise regarding the optimal dose of anticoagulant intervention in hospitalized patients with COVID-19 and consequently, immediate answers from high-quality randomized trials are needed.
Methods: The World Health Organization's International Clinical Trials Registry Platform was searched on June 17, 2020 for randomized controlled trials comparing increased dose to standard dose anticoagulant interventions in hospitalized COVID-19 patients. Two authors independently screened the full records for eligibility and extracted data in duplicate.
Results: A total of 20 trials were included in the review. All trials are open-label, 5 trials use an adaptive design, 1 trial uses a factorial design, 2 trials combine multi-arm parallel group and factorial designs in flexible platform trials, and at least 15 trials have multiple study sites. With individual target sample sizes ranging from 30 to 3,000 participants, the pooled sample size of all included trials is 12,568 participants. Two trials include only ICU patients, and 10 trials base patient eligibility on elevated D-dimer levels. Therapeutic intensity anticoagulation is evaluated in 14 trials. All-cause mortality is part of the primary outcome in 14 trials.
Discussion: Several trials evaluate different dose regimens of anticoagulant interventions in hospitalized patients with COVID-19. Since these trials compete for sites and study participants, a collaborative effort is needed to complete trials faster, conduct pooled analyses and bring effective interventions to patients more quickly.
Keywords: Anticoagulant; COVID-19; Pulmonary Embolism; Research Networks; Thrombosis.