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Completed

NCT Number: NCT05496816

Coagulation Disturbances in COVID-19 Septic Patients

Objective of this study was to determine the relationship between CAC and septic condition in COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP), fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill patients.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all adult critically ill patients tested positive for reverse transcriptase polymerase chain reaction (RT-PCR) of nasopharyngeal swabs to coronavirus 2 (SARS-CoV-2)
  • patienets admitted to the ICU and presented with acute hypoxemic respirator failure

Exclusion criteria

  • patients younger than 18,
  • immunodeficient patients,
  • patients with a history of malignancies,
  • patients who developed septic state before admission,
  • patients with a history of previous coagulopathy, liver and platelet disease.

Treatment and study plan

CAC in septic patients

Diagnostic Test

Data collected included demographic parameters, comorbidities, vasopressors requirement, laboratory findings, in-hospital mortality scoring and diagnostic colagulation scores. Demographic parameters were taken on the day of admission, all other variables were taken on the day of admission to the ICU and on the day of initiation of invasive mechanical ventilation or on the day of discharge from the ICU.

Demographic parameters included age and sex of the patient, followed by comorbidities which was marked with Yes or No on the day of admission in the ICU. Mortality was assessed according to the qSOFA score and vasopressor requirements on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge. Laboratory analysis included analysis of platelets, neutrophils, lymphocytes, PCT, CRP, fibrinogen, D-dimer on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge.

Primary outcomes

  1. Number of patients with coagulation disorder

    Time frame: 1 year

    Laboratory analysis included analysis of platelets, neutrophils, lymphocytes, PCT, CRP, fibrinogen, D-dimer on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital Zenica

Other

Registry information

Official study title

COVID-19 Associated Coagulopathy (CAC) in Septic Critically Ill Patients- a Retrospective Cohort Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2022
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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