How Important Are Hematological Parameters in the Prognosis of Severe Covid-19 Patients?

December 13, 2022 updated by: Ramazan Gozukucuk, Hisar Intercontinental Hospital

Department of Infectious Disease and Clinical Microbiology

It is aimed to reveal the treatment and prognostic values by evaluating the differences in hematological parameters and indices, especially in dead Covid-19 cases.

Material Method: It is planned to retrospectively examine the hemogram parameters of 125 male, 44 female and 169 critical Covid-19 patients hospitalized between 01.03.2020 and 31.12.2021. Subjects were divided into 2 groups as deceased (77) and living (92) patients according to demographic data such as age and gender.

Statistical evaluation: All analyzes were SPSS 25.0, Kolmogorov Smirnov test was used to determine distribution, median and interquartile range (Tukey's Hinges Percentile) were used to summarize variables. The differences between the Independent-Samples Mann Whitney U Test and the data of the patient groups and the optimal cut-off values, sensitivity and specificity values will be determined by ROC analysis. It will be considered statistically significant when the p value is below 0.05 (with the two-tailed test)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to examine the effectiveness of routine laboratory complete blood count parameters and rates as diagnostic and prognostic criteria in severe COVID-19.

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Hisar Hospital Intercontinental

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study had 169 patients in all, including 44 women and 125 males

Description

Inclusion Criteria:

  1. Patients over the age of 18
  2. Critical patients taken to intensive care
  3. The length of stay in the ICU is more than 24 hours

Exclusion Criteria:

1) Patients under 18 years of age (2) Patients with hematological malignancies (3) The length of stay in the ICU is less than 24 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid-19 Survivor groups
Covid-19 survivor groups are hematological parameters
Diagnostic test: Hemogram
Sysmex XN-1000 hematological analyzer
Covid-19 Non-survivor groups
Hematological parameters in patients with severe COVID-19 who have died.
Diagnostic test: Hemogram
Sysmex XN-1000 hematological analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematological parameters in the prognosis of severe Covid-19 patients.
Time Frame: 2020-2021
Hemogram values of the deceased and surviving patients participating in the study were compared.
2020-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hisar Intercontinental Hospital

Investigators

  • Study Chair: Ramazan Gozukucuk, Istanbul Galata Universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HisarIH-125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After accepted by Journal.

IPD Sharing Time Frame

Between 1 March 2020 and 31 December 2021

IPD Sharing Access Criteria

All of result open accses.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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