Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit

• DOI: 10.1001/jama.2021.4152
• Publication Date: 2021-03-18T15:00:30Z
• Authors: Saeideh Mazloomzadeh; Shiva Khaleghparast; Behshid Ghadrdoost; Mostafa Mousavizadeh; Mohammad Reza Baay; Feridoun Noohi; Hamidreza Sharifnia; Arezoo Ahmadi; Sasan Tavan; Nasser Malekpour ...; Mohammad Fathi; Mahshid Soleimanz...; Mostafa Mostafa; Navid Davoody; Maryam Zarinsadaf; Sara Tayyebi; Fahimeh Farrokhzadeh; Faeze Nezamabadi; Esmaeil Soomari; Parham Sadeghipour; Azita H. Talasaz; Farid Rashidi; Babak Sharif-Kashani; Mohammad Taghi Be...; Mohsen Farrokhpour; Seyed Hashem Sezavar; Pooya Payandemehr; Ali Dabbagh; Keivan Gohari Mog...; Sepehr Jamalkhani; Hossein Khalili; Mahdi Yadollahzadeh; Taghi Riahi; Parisa Rezaeifar; Ouria Tahamtan; Samira Matin; Atefeh Abedini; Somayeh Lookzadeh; Hamid Rahmani; Elnaz Zoghi; Keyhan Mohammadi; Pardis Sadeghipour; Homa Abri; Sanaz Tabrizi; Seyed Masoud Mous...; Shaghayegh Shahmi...; Hooman Bakhshandeh; Ahmad Amin; Farnaz Rafiee; Elahe Baghizadeh; Bahram Mohebbi; Seyed Ehsan Parhi...; Rasoul Aliannejad; Vahid Eslami; Alireza Kashefizadeh; Hessam Kakavand; Seyed Hossein Hos...; Shadi Shafaghi; Samrand Fattah Ghazi; Atabak Najafi; David Jimenez; Aakriti Gupta; Mahesh V. Madhavan; Sanjum S. Sethi; Sahil A. Parikh; Manuel Monreal; Naser Hadavand; Alireza Hajighasemi; Majid Maleki; Saeed Sadeghian; Gregory Piazza; Ajay J. Kirtane; Benjamin W. Van T...; Paul P. Dobesh; Gregg W. Stone; Gregory Y. H. Lip; Harlan M. Krumholz; Samuel Z. Goldhaber; Behnood Bikdeli
• Keywords: Male; Hemorrhage; Iran; Drug Administration Schedule; 03 medical and health sciences; Extracorporeal Membrane Oxygenation; 0302 clinical medicine; Outcome Assessment, Health Care; Odds Ratio; Humans; Enoxaparin; Aged; Oxygen Inhalation Therapy; Anticoagulants; COVID-19; Length of Stay; Middle Aged; 16. Peace & justice; Thrombocytopenia; 3. Good health; Hospitalization; Intensive Care Units; Female; Pulmonary Embolism

Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis.To evaluate effects intermediate-dose vs standard-dose prophylactic anticoagulation among COVID-19 admitted intensive care unit (ICU).Multicenter randomized trial a 2 × factorial design performed 10 academic centers Iran comparing (first hypothesis) and statin therapy matching placebo (second hypothesis; not this article) adult ICU Patients were recruited between July 29, 2020, November 19, 2020. The final follow-up date for 30-day primary outcome was December 2020.Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) standard 40 mg 286), modification according body weight creatinine clearance. assigned treatments planned be continued until completion follow-up.The efficacy composite venous or arterial thrombosis, treatment extracorporeal membrane oxygenation, mortality within 30 days, assessed who met eligibility criteria received at least dose treatment. Prespecified safety outcomes included major bleeding Bleeding Academic Research Consortium (type 3 5 definition), powered noninferiority (a margin 1.8 based on odds ratio), severe thrombocytopenia (platelet count <20 ×103/µL). All blindly adjudicated.Among 600 patients, 562 (93.7%) analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). occurred 126 (45.7%) group (44.1%) prophylaxis (absolute risk difference, 1.5% [95% CI, -6.6% 9.8%]; ratio, 1.06 0.76-1.48]; P .70). Major 7 (2.5%) 4 (1.4%) (risk 1.1% [1-sided 97.5% -∞ 3.4%]; 1.83 0.00-5.93]), meeting (P >.99). Severe only (6 0 patients; 2.2% 0.4%-3.8%]; .01).Among COVID-19, anticoagulation, compared did result significant difference adjudicated days. These results do support routine empirical use unselected COVID-19.ClinicalTrials.gov Identifier: NCT04486508.