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1. Simvastatin in Critically Ill Patients with Covid-19.

Author

Hills, Thomas, Lorenzi, Elizabeth, Berry, Lindsay, Shyamsundar, Murali, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen, Aryal, Diptesh, Au, Carly, Beane, Abigail, Bhimani, Zahra, Bonten, Marc, Bradbury, Charlotte, Brunkhorst, Frank, Burrell, Aidan, Buxton, Meredith, Calfee, Carolyn, Cecconi, Maurizio, Cheng, Allen, Cove, Matthew, Detry, Michelle, Estcourt, Lise, Fitzgerald, Mark, Goligher, Ewan, Goossens, Herman, Green, Cameron, Haniffa, Rashan, Harrison, David, Hashmi, Madiha, Higgins, Alisa, Huang, David, Ichihara, Nao, Jayakumar, Deva, Kruger, Peter, Lamontagne, François, Lampro, Lamprini, Lawler, Patrick, Marshall, John, Mason, Alexina, McGlothlin, Anna, McGuinness, Shay, McQuilten, Zoe, McVerry, Bryan, Mouncey, Paul, Murthy, Srinivas, Neal, Matthew, Nichol, Alistair, OKane, Cecilia, Parke, Rachael, Parker, Jane, Rabindrarajan, Ebenezer, Reyes, Luis, Rowan, Kathryn, Saito, Hiroki, Santos, Marlene, Saunders, Christina, Seymour, Christopher, Shankar-Hari, Manu, Sinha, Pratik, Thompson, B, Turgeon, Alexis, Turner, Anne, van de Veerdonk, Frank, Weis, Sebastian, Young, Ian, Zarychanski, Ryan, McArthur, Colin, Angus, Derek, Berry, Scott, Derde, Lennie, Webb, Steve, Gordon, Anthony, McAuley, Daniel, and Lewis, Roger

Subjects
Humans, Bayes Theorem, COVID-19, COVID-19 Drug Treatment, Critical Illness, Hospital Mortality, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Simvastatin, Treatment Outcome
Abstract

BACKGROUND: The efficacy of simvastatin in critically ill patients with coronavirus disease 2019 (Covid-19) is unclear. METHODS: In an ongoing international, multifactorial, adaptive platform, randomized, controlled trial, we evaluated simvastatin (80 mg daily) as compared with no statin (control) in critically ill patients with Covid-19 who were not receiving statins at baseline. The primary outcome was respiratory and cardiovascular organ support-free days, assessed on an ordinal scale combining in-hospital death (assigned a value of -1) and days free of organ support through day 21 in survivors; the analyis used a Bayesian hierarchical ordinal model. The adaptive design included prespecified statistical stopping criteria for superiority (>99% posterior probability that the odds ratio was >1) and futility (>95% posterior probability that the odds ratio was

Published
2023

3. The establishment of a multiple myeloma clinical registry in the Asia–Pacific region: The Asia–Pacific Myeloma and Related Diseases Registry (APAC MRDR)

Author

Aoki, Naomi, Chen, Pin-Yen, Chen, Wenming, Chng, Wee Joo, Gan, Gin Gin, Goh, Yeow Tee, Hou, Jian, Huang, Jeffrey, Kim, Kihyun, Lee, Je Jung, Lu, Jin, McQuilten, Zoe K., Min, Chang Ki, Moore, Elizabeth, Oliver, Laura, Waters, Neil A., Wellard, Cameron, Wood, Erica M., Yeh, Su-Peng, and Spencer, Andrew

Published
2024
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4. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.

Author

Tong, Steven, Mora, Jocelyn, Bowen, Asha, Cheng, Matthew, Daneman, Nick, Goodman, Anna, Heriot, George, Lee, Todd, Lewis, Roger, Lye, David, Mahar, Robert, Marsh, Julie, McGlothlin, Anna, McQuilten, Zoe, Morpeth, Susan, Paterson, David, Price, David, Roberts, Jason, Robinson, J, van Hal, Sebastiaan, Walls, Genevieve, Webb, Steve, Whiteway, Lyn, Yahav, Dafna, and Davis, Joshua

Subjects
Staphylococcus aureus, adaptive platform, bacteremia, bloodstream infection, randomized controlled trial, Humans, Anti-Bacterial Agents, Bacteremia, Staphylococcal Infections, Staphylococcus aureus
Abstract

Staphylococcus aureus bloodstream (SAB) infection is a common and severe infectious disease, with a 90-day mortality of 15%-30%. Despite this,

Published
2022

9. Prophylactic platelet transfusion response in critically ill patients: a prospective multicentre observational study

Author

Reizine, Florian, Le Marec, Sarah, Le Meur, Anthony, Consigny, Maëlys, Berteau, Florian, Bodenes, Laetitia, Geslain, Marie, McQuilten, Zoe, Le Niger, Catherine, Huntzinger, Julien, Seguin, Philippe, Thibert, Jean-Baptiste, Simon, David, Reignier, Jean, Egreteau, Pierre-Yves, Tadié, Jean-Marc, Huet, Olivier, Asfar, Pierre, Ehrmann, Stephan, and Aubron, Cécile

Published
2023
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13. Economic evaluation: immunoglobulin vs prophylactic antibiotics in hypogammaglobulinemia and hematological malignancies

Author

Carrillo de Albornoz, Sara, Higgins, Alisa M., Petrie, Dennis, Irving, Adam, Fanning, Laura, Weinkove, Robert, Crispin, Philip, Dendle, Claire, Gilbertson, Michael, Johnston, Anna, Keegan, Anastazia, Pepperell, Dominic, Pullon, Humphrey, Reynolds, John, van Tonder, Tina, Trotman, Judith, Waters, Neil, Wellard, Cameron, Weston, Helen, Morrissey, C. Orla, Wood, Erica M., and McQuilten, Zoe K.

Published
2024
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14. Immunoglobulin replacement vs prophylactic antibiotics for hypogammaglobulinemia secondary to hematological malignancy

Author

McQuilten, Zoe K., Weinkove, Robert, Thao, Le Thi Phuong, Crispin, Philip, Degelia, Amber, Dendle, Claire, Gilbertson, Michael, Johnston, Anna, Keegan, Anastazia, Pepperell, Dominic, Pullon, Humphrey, Reynolds, John, van Tonder, Tina, Trotman, Judith, Waters, Neil, Wellard, Cameron, Weston, Helen, Morrissey, C. Orla, and Wood, Erica M.

Published
2024
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15. Heparin Dose Intensity and Organ Support-Free Days in Patients Hospitalized for COVID-19

Author

Godoy, Lucas C., Neal, Matthew D., Goligher, Ewan C., Cushman, Mary, Houston, Brett L., Bradbury, Charlotte A., McQuilten, Zoe K., Tritschler, Tobias, Kahn, Susan R., Berry, Lindsay R., Lorenzi, Elizabeth, Jensen, Tom, Higgins, Alisa M., Kornblith, Lucy Z., Berger, Jeffrey S., Gong, Michelle N., Paul, Jonathan D., Castellucci, Lana A., Le Gal, Grégoire, Lother, Sylvain A., Rosenson, Robert S., Derde, Lennie P.G., Kumar, Anand, McVerry, Bryan J., Nicolau, Jose C., Leifer, Eric, Escobedo, Jorge, Huang, David T., Reynolds, Harmony R., Carrier, Marc, Kim, Keri S., Hunt, Beverley J., Slutsky, Arthur S., Turgeon, Alexis F., Webb, Steven A., McArthur, Colin J., Farkouh, Michael E., Hochman, Judith S., Zarychanski, Ryan, and Lawler, Patrick R.

Published
2024
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17. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

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, and Le Gal, Grégoire

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Comparative Effectiveness Research, Cardiovascular, Good Health and Well Being, Aged, Anticoagulants, COVID-19, Critical Illness, Female, Hemorrhage, Heparin, Hospital Mortality, Humans, Logistic Models, Male, Middle Aged, Odds Ratio, Respiration, Artificial, Thrombosis, Treatment Failure, COVID-19 Drug Treatment, REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis 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.MethodsIn 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.ResultsThe 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

Published
2021

18. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

Author

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, and Krishnan, Vidya

Subjects
Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Hematology, Transplantation, Good Health and Well Being, Adult, Aged, Anticoagulants, COVID-19, Female, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Hospital Mortality, Humans, Male, Middle Aged, Survival Analysis, Thrombosis, COVID-19 Drug Treatment, ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis 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.MethodsIn 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.ResultsThe 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.ConclusionsIn 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, NCT04359277, and NCT02735707.).

Published
2021

19. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19.

Author

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, and Kutcher, Matthew E

Subjects
REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Humans, Thrombosis, Critical Illness, Hemorrhage, Heparin, Anticoagulants, Treatment Failure, Respiration, Artificial, Hospital Mortality, Logistic Models, Odds Ratio, Aged, Middle Aged, Female, Male, COVID-19, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis 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.MethodsIn 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.ResultsThe 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

Published
2021

20. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.

Author

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, and King, Andrew J

Subjects
ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Humans, Thrombosis, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Anticoagulants, Hospital Mortality, Survival Analysis, Adult, Aged, Middle Aged, Female, Male, COVID-19, Hematology, Clinical Trials and Supportive Activities, Transplantation, Clinical Research, Cardiovascular, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis 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.MethodsIn 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.ResultsThe 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.ConclusionsIn 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, NCT04359277, and NCT02735707.).

Published
2021

23. The Australian Aplastic Anaemia and other Bone Marrow Failure Syndromes Registry

Author

Fox, Lucy C., McQuilten, Zoe K., Firkin, Frank, Fox, Vanessa, Badoux, Xavier, Bajel, Ashish, Barbaro, Pasquale, Cole-Sinclair, Merrole F., Forsyth, Cecily, Gibson, John, Hiwase, Devendra K., Johnston, Anna, Mills, Anthony, Roncolato, Fernando, Sutherland, Robyn, Szer, Jeff, Ting, Stephen B., Vilcassim, Shahla, Young, Lauren, Waters, Neil A., and Wood, Erica M.

Published
2023
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27. Anti-Factor-Xa and Activated Partial Thromboplastin Time Concordance and Outcomes in Adults Undergoing Extracorporeal Membrane Oxygenation: A Secondary Analysis of the Pilot Low-Dose Heparin in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation Randomized Trial

Author

Aubron, Cécile, Chapalain, Xavier, Bailey, Michael, Board, Jasmin, Buhr, Heidi, Cartwright, Bruce, Dennis, Mark, Hodgson, Carol, Forrest, Paul, McIlroy, David, Murphy, Deirdre, Murray, Lynne, Pellegrino, Vincent, Pilcher, David, Sheldrake, Jayne, Tran, Huyen, Vallance, Shirley, Cooper, D. James, and McQuilten, Zoe

Published
2023
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31. Postnatal treatment for children with fetal and neonatal alloimmune thrombocytopenia: a multicentre, retrospective, cohort study

Author

de Vos, Thijs W, Winkelhorst, Dian, Árnadóttir, Valgerdur, van der Bom, Johanna G, Canals Surís, Carme, Caram-Deelder, Camila, Deschmann, Emöke, Haysom, Helen E, Hverven, Hem Birgit C, Lozar Krivec, Jana, McQuilten, Zoe K, Muñiz-Diaz, Eduardo, Nogués, Núria, Oepkes, Dick, Porcelijn, Leendert, van der Schoot, C Ellen, Saxonhouse, Matthew, Sola-Visner, Martha, Tiblad, Eleonor, Tiller, Heidi, Wood, Erica M, Young, Vanessa, Železnik, Mojca, de Haas, Masja, and Lopriore, Enrico

Published
2022
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33. Illustrated State‐of‐the‐Art Capsules of the ISTH 2022 Congress

Author

Ariëns, Robert A., Hunt, Beverley J., Agbani, Ejaife O., Ahnström, Josefin, Ahrends, Robert, Alikhan, Raza, Assinger, Alice, Bagoly, Zsuzsa, Balduini, Alessandra, Barbon, Elena, Barrett, Christopher D., Batty, Paul, Carneiro, Jorge David Aivazoglou, Chan, Wee Shian, de Maat, Moniek, de Wit, Kerstin, Denis, Cécile, Ellis, Martin H., Eslick, Renee, Fu, Hongxia, Hayward, Catherine P.M., Ho‐Tin‐Noé, Benoit, Klok, Frederikus A., Kumar, Riten, Leiderman, Karin, Litvinov, Rustem I., Mackman, Nigel, McQuilten, Zoe, Neal, Matthew D., Parker, William A.E., Preston, Roger J.S., Rayes, Julie, Rezaie, Alireza R., Roberts, Lara N., Rocca, Bianca, Shapiro, Susan, Siegal, Deborah M., Sousa, Lirlândia P., Suzuki‐Inoue, Katsue, Zafar, Tahira, and Zhou, Jiaxi

Published
2022
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35. ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trial

Author

Denholm, Justin T., Venkatesh, Balasubramanian, Davis, Joshua, Bowen, Asha C., Hammond, Naomi E., Jha, Vivekanand, McPhee, Grace, McQuilten, Zoe, O’Sullivan, Matthew V. N., Paterson, David, Price, David, Rees, Megan, Roberts, Jason, Jones, Mark, Totterdell, James, Snelling, Thomas, Trask, Nanette, Morpeth, Susan, and Tong, Steven YC

Published
2022
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37. The impact of biomarkers of malignancy (IMWG SLiM criteria) in myeloma in a real‐world population: Clinical characteristics, therapy and outcomes from the Australian and New Zealand Myeloma and Related Diseases Registry (ANZ MRDR).

Author

Ho, P. Joy, Moore, Elizabeth, Wellard, Cameron, Quach, Hang, Blacklock, Hilary, Harrrison, Simon J., MacDonald, Emma‐Jane, McQuilten, Zoe K., Wood, Erica M., Mollee, Peter, and Spencer, Andrew

Subjects
PLASMA cells, TREATMENT effectiveness, MEDICAL registries, OVERALL survival, SURVIVAL rate
Abstract

Summary: A decade after International Myeloma Working Group (IMWG) biomarkers (SLiM criteria) were introduced, this real‐world study examined their impact on diagnosis, therapy and outcomes in myeloma. Using the ANZ MRDR, 3489 newly diagnosed patients from 2013 to 2023, comprising 3232 diagnosed by CRAB ('CRAB patients', including 1758 who also satisfied ≥1 SLiM criteria) and 257 by SLiM ('SLiM patients') criteria were analysed. CRAB patients had higher R‐ISS and lower performance status, with no difference in cytogenetic risk. SLiM patients had improved progression‐free survival (PFS, 37.5 vs. 32.2 months, hazard ratio [HR] 1.31 [1.08–1.59], p = 0.003), overall survival (80.9 vs. 73.2 months, HR 1.64 [1.26–2.13], p < 0.001) and PFS2 (54.6 vs. 40.3 months, HR 1.51 [1.22–1.86], p < 0.001) compared with CRAB patients, partially explained by earlier diagnosis, with no differential impact between the plasma cell and light‐chain criteria on PFS. However, 34% of CRAB patients did not manifest SLiM characteristics, raising the possibility that SLiM features are associated with different biological behaviours contributing to a better prognosis, for example, improved PFS2 in SLiM patients suggested less disease resistance at first relapse. These data support earlier initiation of therapy by SLiM. The superior survival outcomes of SLiM versus CRAB patients highlight the importance of defining these subgroups when interpreting therapeutic outcomes at induction and first relapse. [ABSTRACT FROM AUTHOR]

Published
2024
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38. Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage

Author

Caram-Deelder, Camila, primary, McKinnon Edwards, Hellen, additional, Zdanowicz, Jarmila A., additional, van den Akker, Thomas, additional, Birkegård, Camilla, additional, Blatný, Jan, additional, van der Bom, Johanna G., additional, Colucci, Giuseppe, additional, van Duuren, Derek, additional, van Geloven, Nan, additional, Henriquez, Dacia D. C. A., additional, Knight, Marian, additional, Korsholm, Lars, additional, Landorph, Andrea, additional, Lavigne Lissalde, Géraldine, additional, McQuilten, Zoe K., additional, Surbek, Daniel, additional, Wellard, Cameron, additional, Wood, Erica M., additional, and Mercier, Frederic J., additional

Published
2024
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43. Current state and potential applications of neonatal Fc receptor (FcRn) inhibitors in hematologic conditions.

Author

Jacobs, Jeremy W., Booth, Garrett S., Raza, Sheharyar, Clark, Landon M., Fasano, Ross M., Gavriilaki, Eleni, Abels, Elizabeth A., Binns, Thomas C., Duque, Miriam Andrea, McQuilten, Zoe K., Mingot‐Castellano, María Eva, Savani, Bipin N., Sharma, Deva, Tran, Minh‐Ha, Tormey, Christopher A., Moise, Kenneth J., Bloch, Evan M., and Adkins, Brian D.

Published
2024
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44. Heparin Dose Intensity and Organ Support-Free Days in Patients Hospitalized for COVID-19

Author

Medische Staf Intensive Care, Infection & Immunity, Godoy, Lucas C., Neal, Matthew D., Goligher, Ewan C., Cushman, Mary, Houston, Brett L., Bradbury, Charlotte A., McQuilten, Zoe K., Tritschler, Tobias, Kahn, Susan R., Berry, Lindsay R., Lorenzi, Elizabeth, Jensen, Tom, Higgins, Alisa M., Kornblith, Lucy Z., Berger, Jeffrey S., Gong, Michelle N., Paul, Jonathan D., Castellucci, Lana A., Le Gal, Grégoire, Lother, Sylvain A., Rosenson, Robert S., Derde, Lennie P.G., Kumar, Anand, McVerry, Bryan J., Nicolau, Jose C., Leifer, Eric, Escobedo, Jorge, Huang, David T., Reynolds, Harmony R., Carrier, Marc, Kim, Keri S., Hunt, Beverley J., Slutsky, Arthur S., Turgeon, Alexis F., Webb, Steven A., McArthur, Colin J., Farkouh, Michael E., Hochman, Judith S., Zarychanski, Ryan, Lawler, Patrick R., Medische Staf Intensive Care, Infection & Immunity, Godoy, Lucas C., Neal, Matthew D., Goligher, Ewan C., Cushman, Mary, Houston, Brett L., Bradbury, Charlotte A., McQuilten, Zoe K., Tritschler, Tobias, Kahn, Susan R., Berry, Lindsay R., Lorenzi, Elizabeth, Jensen, Tom, Higgins, Alisa M., Kornblith, Lucy Z., Berger, Jeffrey S., Gong, Michelle N., Paul, Jonathan D., Castellucci, Lana A., Le Gal, Grégoire, Lother, Sylvain A., Rosenson, Robert S., Derde, Lennie P.G., Kumar, Anand, McVerry, Bryan J., Nicolau, Jose C., Leifer, Eric, Escobedo, Jorge, Huang, David T., Reynolds, Harmony R., Carrier, Marc, Kim, Keri S., Hunt, Beverley J., Slutsky, Arthur S., Turgeon, Alexis F., Webb, Steven A., McArthur, Colin J., Farkouh, Michael E., Hochman, Judith S., Zarychanski, Ryan, and Lawler, Patrick R.

Published
2024

45. Developing and validating a discrete-event simulation model of multiple myeloma disease outcomes and treatment pathways using a national clinical registry.

Author

Irving, Adam, Petrie, Dennis, Harris, Anthony, Fanning, Laura, Wood, Erica M., Moore, Elizabeth, Wellard, Cameron, Waters, Neil, Huynh, Kim, Augustson, Bradley, Cook, Gordon, Gay, Francesca, McCaughan, Georgia, Mollee, Peter, Spencer, Andrew, and McQuilten, Zoe K.

Subjects
PLASMA cells, MULTIPLE myeloma, STEM cell transplantation, THERAPEUTICS, BONE marrow cells, SURVIVAL analysis (Biometry)
Abstract

Multiple myeloma is a haematological malignancy typically characterised by neoplastic plasma cell infiltration of the bone marrow. Treatment for multiple myeloma consists of multi-line chemotherapy with or without autologous stem cell transplantation and has been rapidly evolving in recent years. However, clinical trials are unable to provide patients and clinicians with long-term prognostic information nor policymakers with the full body of evidence needed to perform economic evaluation of new therapies or make reimbursement decisions. To address these limitations of the available evidence, this study aimed to develop and validate the EpiMAP Myeloma model, a discrete-event simulation model of multiple myeloma disease outcomes and treatment pathways. Risk equations were estimated using the Australian and New Zealand Myeloma & Related Diseases Registry after multiple imputation of missing data. Risk equation coefficients were combined with multiple myeloma patients at diagnosis from the Registry to perform the simulation. The model was validated with 100 bootstraps of an out-of-sample prediction analysis using a 70/30 split of the 4,121 registry patients diagnosed between 2009 and 2023, resulting in 2,884 and 1,237 patients in the training and validation cohorts, respectively. For 90% of the 120 months in the 10-year post-diagnosis period, there was no significant difference in overall survival between the validation and simulated cohorts. These results highlight that the EpiMAP Myeloma model is robust at predicting multiple myeloma disease outcomes and treatment pathways in Australia & New Zealand. In the future, clinicians will be able to use the EpiMAP Myeloma model to provide personalised estimates of life expectancy to patients based on their specific characteristics, disease stage, and response to treatment. Policymakers will also be able to use the model to perform economic evaluation, to forecast the number of patients receiving treatment at different stages, and to determine the downstream impact of listing new, effective therapies. [ABSTRACT FROM AUTHOR]

Published
2024
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46. Neutropenic Sepsis in the Intensive Care Unit: Differences in Clinical Profile and Outcomes According to the Cause of Neutropenia.

Author

MacPhail, Aleece, Dendle, Claire, Slavin, Monica, Weinkove, Robert, Bailey, Michael, Pilcher, David, and McQuilten, Zoe

Subjects
INTENSIVE care units, SEPSIS, NEUTROPENIA, TREATMENT effectiveness, HEMATOLOGIC malignancies
Abstract

Background Neutropenic sepsis frequently requires admission to an intensive care unit (ICU). Differences between subgroups of patients with neutropenic sepsis are not well characterized. Aims To investigate clinical outcomes among patients with neutropenic sepsis and hematological malignancy, metastatic solid cancer, or no cancer diagnosis. Methods Retrospective cohort study of all patients admitted to ICU in Australia or New Zealand between January 2000 and December 2022 with a primary admission diagnosis of sepsis and total white cell count <1.0 × 109 cells/L. Results We identified 8617 ICU admissions with neutropenic sepsis (hematological malignancy n = 4660; metastatic solid cancer n = 1034; no cancer n = 2800). Patients with hematological malignancy were younger (median, 61.5 years) with low rates of chronic comorbidities (4.7%) and were usually admitted to ICU from the ward (67.4%). Mechanical ventilation rates were 20.2% and in-hospital mortality was 30.6%. Patients with metastatic solid cancers were older (median, 66.3 years), with higher rates of chronic comorbidities (9.9%), and were usually admitted to the ICU from the emergency department (50.8%). Mechanical ventilation rates were 16.9% and in-hospital mortality was 42.4%. Patients with no documented cancer had highest rates of mechanical ventilation (41.7%) and mortality (46.3%). Neutropenia was independently associated with mortality among patients with solid cancers or no cancer but did not confer increased risk among patients with hematological malignancy (odds ratio, 0.98; 95% confidence interval,.90–1.06; P =.60). Conclusions Patients with neutropenic sepsis and hematological malignancy, metastatic solid cancer, or no cancer diagnosis constitute 3 distinct clinical groups. Management approaches should be tailored accordingly. [ABSTRACT FROM AUTHOR]

Published
2024
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47. Efficacy and safety of avatrombopag in combination with immunosuppressive therapy in treatment-naïve and relapsed/refractory severe aplastic anaemia: protocol for the DIAAMOND-Ava-FIRST and DIAAMOND-Ava-NEXT Bayesian Optimal Phase II trials

Author

McQuilten, Zoe, primary, Heritier, Stephane, additional, Fox, Lucy, additional, Fox, Vanessa, additional, Young, Lauren, additional, Blombery, Piers, additional, Cunningham, Ilona, additional, Curnow, Jennifer, additional, Higgins, Alisa, additional, Hiwase, Devendra K, additional, Filshie, Robin, additional, Firkin, Frank, additional, Lacaze, Paul, additional, Mason, Kylie, additional, Mills, Anthony K, additional, Pepperell, Dominic, additional, Patil, Sushrut, additional, Stevenson, William, additional, Szer, Jeff, additional, Waters, Neil, additional, Wilson, Kate, additional, Ting, Stephen, additional, and Wood, Erica, additional

Published
2024
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49. Red cell transfusion thresholds in outpatients with myelodysplastic syndromes: Combined results from two randomized controlled feasibility studies

Author

Buckstein, Rena, primary, Callum, Jeannie, additional, Prica, Anca, additional, Bowen, David, additional, Wells, Richard A., additional, Leber, Brian, additional, Heddle, Nancy, additional, Chodirker, Lisa, additional, Cheung, Matthew, additional, Mozessohn, Lee, additional, Yee, Karen, additional, Gallagher, Jennifer, additional, Parmentier, Anne, additional, Jamula, Erin, additional, McQuilten, Zoe, additional, Wood, Erica M., additional, Weinkov, Robert, additional, Zhang, Liying, additional, Mamedov, Alex, additional, Stanworth, Simon J., additional, and Lin, Yulia, additional

Published
2023
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