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. 2022 Mar 4;2022(3):CD013739. doi: 10.1002/14651858.CD013739.pub2

Santoro 2020.

Study characteristics
Methods
  • Study design: prospective cohort

  • Type of publication: peer reviewed published article

  • Setting and dates: hospital, 23 March 2020‐5 May 2020

  • Country: Spain, Italy, Ecuador, Cuba, Germany, China, Canada, Serbia, USA, Chile, and Colombia

  • Language: English

  • Number of centres: 65 listed hospitals

  • Trial registration number: NCT04334291

Participants
  • Number of participants: 5838 allocated (experimental = 2601; comparator = 3214; 23 excluded from analysis); study authors reported 31 exclusion from analysis due to no available information about anticoagulation

  • Age, years (mean ± SD): 66 ± 15 (experimental), 63 ± 27 (comparator)

  • Gender (male/female): 1561/1040 (experimental), 1864/1350 (comparator)

  • Comorbidities (experimental/comparator): history of cancer 14%/14%, CKD 7%/6%, history of lung disease 21%/17%, history of heart disease 26%/21%, diabetes 21%/17%, hypertension 53%/46%, obesity 24%/21%

  • Confounding factors (experimental/comparator): prior anticoagulation (327 (12%) of included participants had history of anticoagulation treatment), surgery (NR), cancer 14%/14%, antiplatelet use (NR), history of VTE (97 of included participants were taking anticoagulants for previous DVT and PE)

  • Type of ventilator support: during hospitalisation, 13% of participants required non‐invasive ventilation and 7% invasive ventilation


Inclusion criteria
  • Patients discharged (deceased or alive) from any hospital centre with a confirmed diagnosis or a COVID‐19 high suspicion


Exclusion criteria
  • There are no exclusion criteria, except for the patient's explicit refusal to participate

Interventions
  • Experimental: treated during hospitalisations with systemic or prophylactic anticoagulation, including oral, subcutaneous, or IV forms. Of the 2601 participants in this group, 327 (12%) had a history of anticoagulation treatment. Anticoagulation therapy in participants not anticoagulated before admission was given for prophylaxis (lower dose) in 83% of cases, while 15% received a full dose of LMWH, 1% oral anticoagulation with VKA, and 1% DOACs

  • Comparator: without anticoagulation

  • Concomitant therapy (experimental/comparator): NR

  • Duration of follow‐up: mean 15 ± 11 (SD) days

Outcomes Primary (specified)
  • All‐cause death (Time Frame: through study completion, an average of 1 month)


Primary (collected)
  • All‐cause mortality during hospitalisation


Secondary (specified)
  • In hospital stay (days) (time frame: through study completion, an average of 1 month)

  • Heart failure (time frame: through study completion, an average of 1 month)

  • Renal failure (time frame: through study completion, an average of 1 month)

  • Respiratory insufficiency. (time frame: through study completion, an average of 1 month)

  • Upper respiratory tract involvement (time frame: through study completion, an average of 1 month)

  • Pneumonia (time frame: through study completion, an average of 1 month)

  • Sepsis (time frame: through study completion, an average of 1 month)

  • Systemic inflammatory response syndrome (time frame: through study completion, an average of 1 month)

  • Clinically relevant bleeding (time frame: through study completion, an average of 1 month)

  • Other complications (time frame: through study completion, an average of 1 month)


Secondary (collected)
  • Respiratory insufficiency

  • Haemoptysis

  • Embolic events (retrospectively)


Time point reported: during hospitalisation or up to 30 days
Notes
  • Sponsor/funding: quote "Non conditioned grant (Fundación Interhospitalaria para la Investigación cardiovascular, FIC. Madrid, Spain). This nonprofit institution had no role in the study design; collection, analysis, interpretation of data; in the writing of the report; nor in the decision to submit the paper for publication."

  • COIs: quote " Drs. Romero and García Aguado received support for article research from the National Institutes of Health. Dr. Moreno Munguia received support for article research from Instituto de Investigación Sanitaria del Hospital Clínico San Carlos. The remaining authors have disclosed that they do not have any potential conflicts of interest."

  • Protocol available (NCT04334291)