Coagulation Disturbances in COVID-19 Septic Patients

• Sponsor: Cantonal Hospital Zenica (Other)
• Overall Status: Completed
• CT.gov ID: NCT05496816
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coagulation Disorder; COVID 19 Associated Coagulopathy; Sepsis; Septic Shock	Diagnostic Test: CAC in septic patients

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: COVID-19 Associated Coagulopathy (CAC) in Septic Critically Ill Patients- a Retrospective Cohort Study
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sepsis	Diagnostic Test: CAC in septic patients; 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.
Septic shock	Diagnostic Test: CAC in septic patients; 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.

Outcome Measures

Primary Outcome Measures

1. Number of patients with coagulation disorder [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cantonal Hospital	Zenica		Bosnia and Herzegovina	72000

Sponsors and Collaborators

• Cantonal Hospital Zenica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mirza Kovacevic, Anesthesiologist, Cantonal Hospital Zenica
• ClinicalTrials.gov Identifier: NCT05496816
• Other Study ID Numbers: CAC
• First Posted: Aug 11, 2022
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Aug 11, 2022