Browsing by Author "ATTACC Investigators"

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    ItemOpen Access
    Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19.
    (The New England journal of medicine, 2021-08-04) REMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators; Goligher, Ewan C; Bradbury, Charlotte A; McVerry, Bryan J; Lawler, Patrick R; Berger, Jeffrey S; Gong, Michelle N; Carrier, Marc; Reynolds, Harmony R; Kumar, Anand; Turgeon, Alexis F; Kornblith, Lucy Z; Kahn, Susan R; Marshall, John C; Kim, Keri S; Houston, Brett L; Derde, Lennie PG; Cushman, Mary; Tritschler, Tobias; Angus, Derek C; Godoy, Lucas C; McQuilten, Zoe; Kirwan, Bridget-Anne; Farkouh, Michael E; Brooks, Maria M; Lewis, Roger J; Berry, Lindsay R; Lorenzi, Elizabeth; Gordon, Anthony C; Ahuja, Tania; Al-Beidh, Farah; Annane, Djillali; Arabi, Yaseen M; Aryal, Diptesh; Baumann Kreuziger, Lisa; Beane, Abi; Bhimani, Zahra; Bihari, Shailesh; Billett, Henny H; Bond, Lindsay; Bonten, Marc; Brunkhorst, Frank; Buxton, Meredith; Buzgau, Adrian; Castellucci, Lana A; Chekuri, Sweta; Chen, Jen-Ting; Cheng, Allen C; Chkhikvadze, Tamta; Coiffard, Benjamin; Contreras, Aira; Costantini, Todd W; de Brouwer, Sophie; Detry, Michelle A; Duggal, Abhijit; Džavík, Vladimír; Effron, Mark B; Eng, Heather F; Escobedo, Jorge; Estcourt, Lise J; Everett, Brendan M; Fergusson, Dean A; Fitzgerald, Mark; Fowler, Robert A; Froess, Joshua D; Fu, Zhuxuan; Galanaud, Jean P; Galen, Benjamin T; Gandotra, Sheetal; Girard, Timothy D; Goodman, Andrew L; Goossens, Herman; Green, Cameron; Greenstein, Yonatan Y; Gross, Peter L; Haniffa, Rashan; Hegde, Sheila M; Hendrickson, Carolyn M; Higgins, Alisa M; Hindenburg, Alexander A; Hope, Aluko A; Horowitz, James M; Horvat, Christopher M; Huang, David T; Hudock, Kristin; Hunt, Beverley J; Husain, Mansoor; Hyzy, Robert C; Jacobson, Jeffrey R; Jayakumar, Devachandran; Keller, Norma M; Khan, Akram; Kim, Yuri; Kindzelski, Andrei; King, Andrew J; Knudson, M Margaret; Kornblith, Aaron E; Kutcher, Matthew E; Laffan, Michael A; Lamontagne, Francois; Le Gal, Grégoire; Leeper, Christine M; Leifer, Eric S; Lim, George; Gallego Lima, Felipe; Linstrum, Kelsey; Litton, Edward; Lopez-Sendon, Jose; Lother, Sylvain A; Marten, Nicole; Saud Marinez, Andréa; Martinez, Mary; Mateos Garcia, Eduardo; Mavromichalis, Stavroula; McAuley, Daniel F; McDonald, Emily G; McGlothlin, Anna; McGuinness, Shay P; Middeldorp, Saskia; Montgomery, Stephanie K; Mouncey, Paul R; Murthy, Srinivas; Nair, Girish B; Nair, Rahul; Nichol, Alistair D; Nicolau, Jose C; Nunez-Garcia, Brenda; Park, John J; Park, Pauline K; Parke, Rachael L; Parker, Jane C; Parnia, Sam; Paul, Jonathan D; Pompilio, Mauricio; Quigley, John G; Rosenson, Robert S; Rost, Natalia S; Rowan, Kathryn; Santos, Fernanda O; Santos, Marlene; Santos, Mayler O; Satterwhite, Lewis; Saunders, Christina T; Schreiber, Jake; Schutgens, Roger EG; Seymour, Christopher W; Siegal, Deborah M; Silva, Delcio G; Singhal, Aneesh B; Slutsky, Arthur S; Solvason, Dayna; Stanworth, Simon J; Turner, Anne M; van Bentum-Puijk, Wilma; van de Veerdonk, Frank L; van Diepen, Sean; Vazquez-Grande, Gloria; Wahid, Lana; Wareham, Vanessa; Widmer, R Jay; Wilson, Jennifer G; Yuriditsky, Eugene; Zhong, Yongqi; Berry, Scott M; McArthur, Colin J; Neal, Matthew D; Hochman, Judith S; Webb, Steven A; Zarychanski, Ryan

    Background

    Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.

    Methods

    In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.

    Results

    The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis.

    Conclusions

    In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707, NCT04505774, NCT04359277, and NCT04372589.).
  • Thumbnail Image
    ItemOpen Access
    Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.
    (The New England journal of medicine, 2021-08-04) ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators; Lawler, Patrick R; Goligher, Ewan C; Berger, Jeffrey S; Neal, Matthew D; McVerry, Bryan J; Nicolau, Jose C; Gong, Michelle N; Carrier, Marc; Rosenson, Robert S; Reynolds, Harmony R; Turgeon, Alexis F; Escobedo, Jorge; Huang, David T; Bradbury, Charlotte A; Houston, Brett L; Kornblith, Lucy Z; Kumar, Anand; Kahn, Susan R; Cushman, Mary; McQuilten, Zoe; Slutsky, Arthur S; Kim, Keri S; Gordon, Anthony C; Kirwan, Bridget-Anne; Brooks, Maria M; Higgins, Alisa M; Lewis, Roger J; Lorenzi, Elizabeth; Berry, Scott M; Berry, Lindsay R; Aday, Aaron W; Al-Beidh, Farah; Annane, Djillali; Arabi, Yaseen M; Aryal, Diptesh; Baumann Kreuziger, Lisa; Beane, Abi; Bhimani, Zahra; Bihari, Shailesh; Billett, Henny H; Bond, Lindsay; Bonten, Marc; Brunkhorst, Frank; Buxton, Meredith; Buzgau, Adrian; Castellucci, Lana A; Chekuri, Sweta; Chen, Jen-Ting; Cheng, Allen C; Chkhikvadze, Tamta; Coiffard, Benjamin; Costantini, Todd W; de Brouwer, Sophie; Derde, Lennie PG; Detry, Michelle A; Duggal, Abhijit; Džavík, Vladimír; Effron, Mark B; Estcourt, Lise J; Everett, Brendan M; Fergusson, Dean A; Fitzgerald, Mark; Fowler, Robert A; Galanaud, Jean P; Galen, Benjamin T; Gandotra, Sheetal; García-Madrona, Sebastian; Girard, Timothy D; Godoy, Lucas C; Goodman, Andrew L; Goossens, Herman; Green, Cameron; Greenstein, Yonatan Y; Gross, Peter L; Hamburg, Naomi M; Haniffa, Rashan; Hanna, George; Hanna, Nicholas; Hegde, Sheila M; Hendrickson, Carolyn M; Hite, R Duncan; Hindenburg, Alexander A; Hope, Aluko A; Horowitz, James M; Horvat, Christopher M; Hudock, Kristin; Hunt, Beverley J; Husain, Mansoor; Hyzy, Robert C; Iyer, Vivek N; Jacobson, Jeffrey R; Jayakumar, Devachandran; Keller, Norma M; Khan, Akram; Kim, Yuri; Kindzelski, Andrei L; King, Andrew J; Knudson, M Margaret; Kornblith, Aaron E; Krishnan, Vidya; Kutcher, Matthew E; Laffan, Michael A; Lamontagne, Francois; Le Gal, Grégoire; Leeper, Christine M; Leifer, Eric S; Lim, George; Lima, Felipe Gallego; Linstrum, Kelsey; Litton, Edward; Lopez-Sendon, Jose; Lopez-Sendon Moreno, Jose L; Lother, Sylvain A; Malhotra, Saurabh; Marcos, Miguel; Saud Marinez, Andréa; Marshall, John C; Marten, Nicole; Matthay, Michael A; McAuley, Daniel F; McDonald, Emily G; McGlothlin, Anna; McGuinness, Shay P; Middeldorp, Saskia; Montgomery, Stephanie K; Moore, Steven C; Morillo Guerrero, Raquel; Mouncey, Paul R; Murthy, Srinivas; Nair, Girish B; Nair, Rahul; Nichol, Alistair D; Nunez-Garcia, Brenda; Pandey, Ambarish; Park, Pauline K; Parke, Rachael L; Parker, Jane C; Parnia, Sam; Paul, Jonathan D; Pérez González, Yessica S; Pompilio, Mauricio; Prekker, Matthew E; Quigley, John G; Rost, Natalia S; Rowan, Kathryn; Santos, Fernanda O; Santos, Marlene; Olombrada Santos, Mayler; Satterwhite, Lewis; Saunders, Christina T; Schutgens, Roger EG; Seymour, Christopher W; Siegal, Deborah M; Silva, Delcio G; Shankar-Hari, Manu; Sheehan, John P; Singhal, Aneesh B; Solvason, Dayna; Stanworth, Simon J; Tritschler, Tobias; Turner, Anne M; van Bentum-Puijk, Wilma; van de Veerdonk, Frank L; van Diepen, Sean; Vazquez-Grande, Gloria; Wahid, Lana; Wareham, Vanessa; Wells, Bryan J; Widmer, R Jay; Wilson, Jennifer G; Yuriditsky, Eugene; Zampieri, Fernando G; Angus, Derek C; McArthur, Colin J; Webb, Steven A; Farkouh, Michael E; Hochman, Judith S; Zarychanski, Ryan

    Background

    Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.

    Methods

    In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.

    Results

    The trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.

    Conclusions

    In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT02735707, and NCT04359277.).