Effectiveness of Thromboprophylaxis With Low Molecular Weight Heparin in Critically Ill Patients With COVID-19. A Prospective, Cohort, Multicenter Study.
Sponsor study identifier
observational
822
1 country
31
Study Start
March 1, 2020
Actual (reported)Primary Completion
September 30, 2020
Actual (reported)Study Completion
November 30, 2020
Actual (reported)The respiratory distress that goes with COVID-19 infection has been related to a procoagulant state, with thrombosis at both venous and arterial levels, that determines hypoxia and tissue dysfunction at several organs. The main sign of this thrombotic activity seems to be the D-Dimers, that have been proposed to identify patients with poor prognosis at an early stage. Knowledge on how to prevent or even treat this procoagulant state is scarce. COVID-19 patients may be out of general thromboprophylaxis recommendations, and recent studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with low molecular weight heparin (LMWH). However, the LMWH efficacy and safety, mainly in patients admitted to an Intensive Care Unit, remains to be validated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2020
Actual (reported)September 30, 2020
Actual (reported)November 2, 2020
Actual (reported)November 10, 2020
Actual (reported)November 30, 2020
Actual (reported)ICU mortality
Rate of mortality
From admission to ICU discharge, an average of 1 month
ICU incidence of thrombotic events
From admission to ICU discharge, an average of 1 month
ICU incidence of bleeding events
From admission to ICU discharge, an average of 1 month
Patients receiving an anticoagulant dose (equal or higher than 150 IU/kg/24 h) of LMWH within the first 48 hours after the ICU admission
Patients receiving a prophylactic dose (lower than 150 IU/kg/24 h) of LMWH within the first 48 hours after the ICU admission
Patients receiving no anticoagulant drug within the first 48 hours after the ICU admission
All consecutive COVID-19 patients admitted to participating ICUs from March 12th to September 1st were included if they fulfill the inclusion criteria and present no exclusion criteria
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Universitario de Araba
Álava, Basque Country, 1009, Spain
Complejo Asistencial Universitario de León
León, Castille and León, 24080, Spain
Hospital Universitario Rio Ortega
Valladolid, Castille and León, 47012, Spain
Hospital General de Ciudad Real
Ciudad Real, Castille-La Mancha, 13005, Spain
Hospital Clinic Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 8041, Spain
Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quere I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17.
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Raquel Ferrandis, MD
Hospital Universitario La Fe
822 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2020
First Posted
November 10, 2020
Study Start
March 1, 2020
Actual (reported)Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19
Length of ICU stay
From admission to ICU discharge, an average of 1 month
Length of invasive mechanical ventilation
From admission to ICU discharge, an average of 1 month
Effect of LMWH in other parameters
From admission to ICU discharge, an average of 1 month
Contact the study team to confirm eligibility.
Hospital de Terrasa
Barcelona, Catalonia, 8227, Spain
Complejo Hospitalario de Cáceres
Cáceres, Extramedura, 10003, Spain
Hospital Unversitario A Coruña
A Coruña, Galicia, 15006, Spain
Complexo Hospitalario Universitario de Ferrol
A Coruña, Galicia, 15405, Spain
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Galicia, 36071, Spain
Hospital Povisa
Pontevedra, Galicia, 36211, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas, Gran Canaria, 35010, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital General Universitario de Alicante
Alicante, Valencia, 3010, Spain
Hospital Universitario San Juan de Alicante
Alicante, Valencia, 3550, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital Sanitas Cima
Barcelona, 8034, Spain
Hospital Sant Joan Despí
Barcelona, 8970, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Infanta Sofia
Madrid, 28702, Spain
Hospital Rafael Méndez
Murcia, 30817, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Universitari La Fe
Valencia, 46026, Spain
Jackson SP, Darbousset R, Schoenwaelder SM. Thromboinflammation: challenges of therapeutically targeting coagulation and other host defense mechanisms. Blood. 2019 Feb 28;133(9):906-918. doi: 10.1182/blood-2018-11-882993. Epub 2019 Jan 14.
Ferrandis R, Llau JV, Quintana M, Sierra P, Hidalgo F, Cassinello C, Gomez-Luque A. COVID-19: opening a new paradigm in thromboprophylaxis for critically ill patients? Crit Care. 2020 Jun 11;24(1):332. doi: 10.1186/s13054-020-03052-9. No abstract available.
Llau JV, Ferrandis R, Sierra P, Hidalgo F, Cassinello C, Gomez-Luque A, Quintana M, Amezaga R, Gero M, Serrano A, Marcos P. SEDAR-SEMICYUC consensus recommendations on the management of haemostasis disorders in severely ill patients with COVID-19 infection. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Aug-Sep;67(7):391-399. doi: 10.1016/j.redar.2020.05.007. Epub 2020 May 23.
Paranjpe I, Fuster V, Lala A, Russak AJ, Glicksberg BS, Levin MA, Charney AW, Narula J, Fayad ZA, Bagiella E, Zhao S, Nadkarni GN. Association of Treatment Dose Anticoagulation With In-Hospital Survival Among Hospitalized Patients With COVID-19. J Am Coll Cardiol. 2020 Jul 7;76(1):122-124. doi: 10.1016/j.jacc.2020.05.001. Epub 2020 May 6. No abstract available.
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Tang N, Bai H, Xiong D, Sun Z. Specific coagulation markers may provide more therapeutic targets in COVID-19 patients receiving prophylactic anticoagulant. J Thromb Haemost. 2020 Sep;18(9):2428-2430. doi: 10.1111/jth.14988. No abstract available.
Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 May;18(5):1094-1099. doi: 10.1111/jth.14817. Epub 2020 Apr 27.
Primary Completion
September 30, 2020
Actual (reported)Study Completion
November 30, 2020
Actual (reported)Last Updated
March 31, 2022
Record last verified: 2020-10
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