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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042717
Receipt No. R000048021
Scientific Title Circulating microparticles as biomarkers in COVID-19 associated coagulopathy: a prospective cohort study
Date of disclosure of the study information 2020/12/10
Last modified on 2020/12/10

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Basic information
Public title The mechanism of COVID-19 associated coagulopathy: a prospective cohort study
Acronym A prospective study of COVID-19 associated coagulopathy
Scientific Title Circulating microparticles as biomarkers in COVID-19 associated coagulopathy: a prospective cohort study
Scientific Title:Acronym The role of microparticles in coagulopathy of COVID-19: a prospective cohort study
Region
Japan

Condition
Condition Patients admitted with COVID-19
Classification by specialty
Hematology and clinical oncology Infectious disease Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the origin of MPs, circulating MPs levels, and the role of MPs in coagulopathy of COVID-19
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The level of Tissue factor bearing microparticles
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
120 years-old >=
Gender Male and Female
Key inclusion criteria Patients admitted with COVID-19
Key exclusion criteria (1) patients in which informed consent could not be obtained from the person or close relatives
(2) patients who have other infectious diseases
(3) patients with end-stage heart failure( defined as NYHA class4)
(4) patients with end-stage liver failure (defined as Child-Pugh classification C)
(5) patients with progressive cancer, or patients undergoing cancer treatment
(6) patients who are pregnant
(7) patients who have participated in this study
(8) patients who are diagnosed as COVID-19 accidentally and need emergency treatment for other diseases
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Saito
Organization Tohoku university hospital
Division name Department of Intensive Care Unit
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Japan
TEL 0227177000
Email koji.saito.e1@tohoku.ac.jp

Public contact
Name of contact person
1st name Yudai
Middle name
Last name Iwasaki
Organization Tohoku university hospital
Division name Department of Anesthesiology and Perioperative Medicine
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Japan
TEL 0227177000
Homepage URL
Email yudai.i0213@gmail.com

Sponsor
Institute Tohoku university
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku university hospital
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Japan
Tel 0227177000
Email med-kenkyo@grp.tohoku.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 10 Month 03 Day
Date of IRB
2020 Year 10 Month 28 Day
Anticipated trial start date
2020 Year 11 Month 09 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are going to evaluate whether microparticles(MPs) are associated with COVID-19 associated coagulopathy. We will collect blood from COVID-19 patients and measure MPs levels. And we assess whether COVID-19 coagulopathic patients have statistically higher MPs levels compared with COVID-19 non-coagulopathic patients.

Management information
Registered date
2020 Year 12 Month 10 Day
Last modified on
2020 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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