Thromboprophylaxis for Patients in ICU With COVID-19

NCT04623177 | Completed

• 1 other identifier: RegCoVid-19
• Study Type: observational
• Target: 822
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Covid19; Anticoagulant Therapy; Thrombosis

Keywords

Covid19; Low Molecular weight heparin; Thromboprophylaxis; Anticoagulant treatment; Thrombosis

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  Rate of mortality

  From admission to ICU discharge, an average of 1 month

Secondary Outcomes (5)

• 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

• 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

Study Arms (3)

Anticoagulation

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

Thromboprophylaxis

Patients receiving a prophylactic dose (lower than 150 IU/kg/24 h) of LMWH within the first 48 hours after the ICU admission

No heparin

Patients receiving no anticoagulant drug within the first 48 hours after the ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Confirmed SARS-CoV2 infection from a respiratory tract sample using a polymerase chain reaction assay.
• Admitted to ICU

You may not qualify if:

• Non-confirmed SARS-CoV2 infection
• No data at first day ICU admission
• Patient with do-not resuscitate orders
• Patient who did not meet the outcomes of death or ICU discharge by the time of study completion date

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• Hospital Universitario Doctor Peset: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Universitario La Fe: collaborator
• Hospital de Sant Joan Despí Moisès Broggi: collaborator
• University of Navarrra Hospital (Clinica Universitaria): collaborator
• Hospital de Cruces: collaborator

Study Sites (31)

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario de Araba

Álava, Basque Country, 1009, Spain

Location

Complejo Asistencial Universitario de León

León, Castille and León, 24080, Spain

Location

Hospital Universitario Rio Ortega

Valladolid, Castille and León, 47012, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, Castille-La Mancha, 13005, Spain

Location

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 8041, Spain

Location

Hospital de Terrasa

Barcelona, Catalonia, 8227, Spain

Location

Complejo Hospitalario de Cáceres

Cáceres, Extramedura, 10003, Spain

Location

Hospital Unversitario A Coruña

A Coruña, Galicia, 15006, Spain

Location

Complexo Hospitalario Universitario de Ferrol

A Coruña, Galicia, 15405, Spain

Location

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Galicia, 36071, Spain

Location

Hospital Povisa

Pontevedra, Galicia, 36211, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas, Gran Canaria, 35010, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital General Universitario de Alicante

Alicante, Valencia, 3010, Spain

Location

Hospital Universitario San Juan de Alicante

Alicante, Valencia, 3550, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital Sanitas Cima

Barcelona, 8034, Spain

Location

Hospital Sant Joan Despí

Barcelona, 8970, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Infanta Sofia

Madrid, 28702, Spain

Location

Hospital Rafael Méndez

Murcia, 30817, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Hospital Universitari La Fe

Valencia, 46026, Spain

Location

Related Publications (9)

• 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.

  PMID: 32311448 BACKGROUND

• 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.

  PMID: 32109013 BACKGROUND

• 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.

  PMID: 30642917 BACKGROUND

• 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.

  PMID: 32527286 BACKGROUND

• 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.

  PMID: 32591185 BACKGROUND

• 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.

  PMID: 32387623 BACKGROUND

• 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.

  PMID: 32171076 BACKGROUND

• 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.

  PMID: 32619329 BACKGROUND

• 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.

  PMID: 32220112 BACKGROUND

MeSH Terms

Conditions

COVID-19; Thrombosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raquel Ferrandis, MD

  Hospital Universitario La Fe

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: March 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 31, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (31)