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Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients

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ClinicalTrials.gov Identifier: NCT04408378
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Gaziosmanpasa Taksim Research and Education Hospital

Tracking Information
First Submitted Date May 27, 2020
First Posted Date May 29, 2020
Last Update Posted Date May 29, 2020
Estimated Study Start Date June 5, 2020
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2020)
estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio [ Time Frame: March-May 2020 ]
İt has been studied that MPV/PLT ratio can show the cl inical couses of several diseases as well as ARDS. we thought that we can identify the coronavirus pneumonia patients earlier, at admission of hospital by using the hemogrames.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients
Official Title Retrospective Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients
Brief Summary Morbidity, mortality and progress depends on systemic inflammation especially in ARDS patients. Previous studies claims that the proportion of mean platellet volume to platellet which can simply be determined with simple blood tests that are performed at admission, might predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for detecting the progress of Covid-19 pneumonia or not.
Detailed Description

Covid-19 pneumonia is a spesific disease dispate its similarity to ARDS. There are nomorous of studies that MPV/PLT ratio can predict the mortality, morbidity and the progress of ARDS. Depending on the similarity of ARDS, MPV/PLT ratio might predict the clinical progress of Covid-19 pneumonia. We retrospectively recruited150 patients admitted to our institute -a tertiary center- with Covid-19 pneumonia to our study. Clinical based defining research, by March-May 2020, the patients over 18 years old who were in either intensive care or ward scanned retrospectively. The laboratory tests, chronic diseases , age and gender has been collected from the written resources and electronic data retrospectively.

the patients who are diagnosed with Covid*19 pneumonia will be divided into two groups. The ones in the ward will be considered as mild clinical course, and the ones in the intensive care unit will be considered as severe clinical course. there will be an additional non Covid individuals as a control group, which will consist 52 patients each. The ratio of MPV to PLT will be calculated using admission hemogrames of these groups, and the significance of the statistical differences on determining the prognosis of the disease will be discussed.

Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.It was done using ANOVA test between at least two independent groups. In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 52 patients which makes at total of 156.

The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be uused in abnormal distrubitions. Between the independent groups, MPV/PLT ratio will be calculated using ANOVA test. Categoric data will be compared by Pearson ki square test and the p values less than 0.05 will be considered as significant.

we aim to have an opinion about Covid 19-pneomonia prognosis at the admission of hospital.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between march and may 2020 in the ICU or ward.
Condition Coronavirus Infection
Intervention Other: observation of covid 19 pneumonia
We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio
Study Groups/Cohorts
  • mild pneumonia
    The patients who has followed in the ward
    Intervention: Other: observation of covid 19 pneumonia
  • severe pneumonia
    The patiens who has followed in the intensive care unit
    Intervention: Other: observation of covid 19 pneumonia
  • control group
    patients who has not covid 19 pneumonia
    Intervention: Other: observation of covid 19 pneumonia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 28, 2020)
156
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 20, 2020
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients over 18 years old who hospitalized with diagnosis of Covid-19 pneumonia between march and may 2020

Exclusion Criteria:

  • Under 18 years old patients
  • Patients with heamolytic diaseses
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04408378
Other Study ID Numbers 69
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Gaziosmanpasa Taksim Research and Education Hospital
Study Sponsor Gaziosmanpasa Taksim Research and Education Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Gaziosmanpasa Taksim Research and Education Hospital
Verification Date May 2020