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

• ClinicalTrials.gov Identifier: NCT04408378
• Recruitment Status: Recruiting
• First Posted: May 29, 2020
• Last Update Posted: May 29, 2020
• Sponsor: Gaziosmanpasa Taksim Research and Education Hospital
• 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 *

• Kim CH, Kim SJ, Lee MJ, Kwon YE, Kim YL, Park KS, Ryu HJ, Park JT, Han SH, Yoo TH, Kang SW, Oh HJ. An increase in mean platelet volume from baseline is associated with mortality in patients with severe sepsis or septic shock. PLoS One. 2015 Mar 5;10(3):e0119437. doi: 10.1371/journal.pone.0119437. eCollection 2015.
• Fei Y, Zhang H, Zhang C. The application of lymphocyte*platelet and mean platelet volume/platelet ratio in influenza A infection in children. J Clin Lab Anal. 2019 Nov;33(9):e22995. doi: 10.1002/jcla.22995. Epub 2019 Aug 16.
• 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

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
• Listed Location Countries: Turkey

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