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Thromboprophylaxis for Patients in ICU With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04623177
Recruitment Status : Active, not recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Hospital Universitario Doctor Peset
Hospital Clinic of Barcelona
Hospital Universitario La Paz
Hospital Universitario La Fe
Hospital de Sant Joan Despí Moisès Broggi
University of Navarrra Hospital (Clinica Universitaria)
Hospital Universitario Cruces
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

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.


Condition or disease
Covid19 Anticoagulant Therapy Thrombosis

Detailed Description:

Many reports have postulated a procoagulant state along with the respiratory distress caused by coronavirus SARS-CoV2. A complex physiopathology has been proposed trying to explain this profile, mainly based on the thromboinflammatory concept, with thrombosis at both venous and arterial levels. Microvascular thrombi impair the blood flow all over the body, with a vascular shunt due to capillary obstruction, that determines hypoxia and tissue dysfunction at several organs, being the lung the more affected one.

Although D-Dimers (DD) are not specific indicators of clot formation, its elevation, in combination with other parameters (hyperfibrinogenemia, mild thrombocytopenia) may suggest a systemic coagulation activation with an increase of thrombin generation and fibrinolysis. In fact, in a retrospective Chinese analysis, a DD higher than 1000 ng/ml was proposed to identify patients with poor prognosis at an early stage.

Nevertheless, knowledge on how to prevent or even treat this procoagulant state is scarce. Thromboprophylaxis with low molecular-weight heparin (LMWH) is recommended in most medical patients admitted to the hospital and in nearly all patients in an Intensive Care Unit (ICU). But COVID-19 patients may be out of these recommendations, and some treatment schemes has been proposed, although how to decide the suitable LMWH for each clinical situation is controversial. Recent retrospective studies suggest a better prognosis in severe COVID-19 patients receiving anticoagulant therapy with LMWH. However, the LMWH efficacy and safety, mainly in COVID-19 patients admitted to the ICU, remains to be validated.

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Study Type : Observational
Estimated Enrollment : 950 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Thromboprophylaxis With Low Molecular Weight Heparin in Critically Ill Patients With COVID-19. A Prospective, Cohort, Multicenter Study.
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : September 30, 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. ICU mortality [ Time Frame: From admission to ICU discharge, an average of 1 month ]
    Rate of mortality


Secondary Outcome Measures :
  1. ICU incidence of thrombotic events [ Time Frame: From admission to ICU discharge, an average of 1 month ]
    A composite endpoint to evaluate efficacy made up of: myocardial infarction, stroke, incidental pulmonary thromboembolism, pulmonary thromboembolism with worsening of hypoxemia, Pulmonary thromboembolism with hemodynamic repercussion, other venous thromboses without pulmonary thromboembolism

  2. ICU incidence of bleeding events [ Time Frame: From admission to ICU discharge, an average of 1 month ]
    Composite endpoint to evaluate safety made up of: bleeding needing transfusion, bleeding wit hemodynamic repercussion, other bleeding (minor bleeding)

  3. Length of ICU stay [ Time Frame: From admission to ICU discharge, an average of 1 month ]
    Days admitted in ICU

  4. Length of invasive mechanical ventilation [ Time Frame: From admission to ICU discharge, an average of 1 month ]
    Days treated with invasive mechanical ventilation (controlled or assisted)

  5. Effect of LMWH in other parameters [ Time Frame: From admission to ICU discharge, an average of 1 month ]
    Description of the relationship if any between the use of LMWH and thrombotic or inflammatory parameters (D-Dimer levels, ferritin) or lung dead space



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623177


Locations
Show Show 31 study locations
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Hospital Universitario Doctor Peset
Hospital Clinic of Barcelona
Hospital Universitario La Paz
Hospital Universitario La Fe
Hospital de Sant Joan Despí Moisès Broggi
University of Navarrra Hospital (Clinica Universitaria)
Hospital Universitario Cruces
Investigators
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Study Chair: Raquel Ferrandis, MD Hospital Universitario La Fe
Publications:
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, Quéré 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. Review.

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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT04623177    
Other Study ID Numbers: RegCoVid-19
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Covid19
Low Molecular weight heparin
Thromboprophylaxis
Anticoagulant treatment
Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases