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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

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.

Condition or disease Intervention/treatment
Coronavirus Infection Other: observation of covid 19 pneumonia

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.

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Study Type : Observational
Estimated Enrollment : 156 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Retrospective Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients
Estimated Study Start Date : June 5, 2020
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
mild pneumonia
The patients who has followed in the ward
Other: observation of covid 19 pneumonia
We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio

severe pneumonia
The patiens who has followed in the intensive care unit
Other: observation of covid 19 pneumonia
We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio

control group
patients who has not covid 19 pneumonia
Other: observation of covid 19 pneumonia
We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408378


Locations
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Turkey
Gaziosmanpaşa TREH Recruiting
Istanbul, Gaziosmanpaşa, Turkey, 34255
Contact: aygen türkmen, MD.prof.    +902129453000 ext 1436    aygenturkmen@hotmail.com   
Principal Investigator: zuhal çavuş, MD         
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital
Publications:
2. Gulseren Yilmaz, Ziya Salihoglu. Do Mean Platelet Volume and Red Cell Distribution Width Predict Mortality in Patients with Acute Respiratory Distress Syndrome? J Immunol Clin Microbiol. 2019;4(4):97-106 3. Aleksandra K, Olga M , Joanna K, Halina K, and Violetta D-P.; Mean Platelet Volume (MPV): New Perspectives for an Old Marker in the Course and Prognosis of Inflammatory Conditions .Hindawi Mediators of Inflammation Volu

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Responsible Party: Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT04408378    
Other Study ID Numbers: 69
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gaziosmanpasa Taksim Research and Education Hospital:
covid-19, MPV/PLT, pneumonia
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases