UMIN-CTR Clinical Trial

Basic information
Public title	THE RELATIONSHIP OF D-DIMER WITH SEVERITY AND MORTALITY IN SARS-COV-2 PATIENTS
Acronym	THE RELATIONSHIP OF D-DIMER WITH SEVERITY AND MORTALITY IN SARS-COV-2
Scientific Title	THE RELATIONSHIP OF D-DIMER WITH SEVERITY AND MORTALITY IN SARS-COV-2 PATIENTS: A META-ANALYSIS
Scientific Title:Acronym	THE RELATIONSHIP OF D-DIMER WITH SEVERITY AND MORTALITY IN SARS-COV-2 PATIENTS
Region	Asia(except Japan)

Condition
Condition	SARS-Cov2
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we perform this meta-analysis aims to determine the evidence-based relationship of D-Dimer with severity and mortality in SARS-CoV-2 patients
Basic objectives2	Others
Basic objectives -Others	relationship to predict outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	D-dimer level on admission based on severity of the case
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	all observational studies or trials that involving adult patients with SARS-CoV-2 that had any data D-dimer on admission for comparison severe vs non-severe; ICU vs non-ICU; survivor vs non-survivor
Key exclusion criteria	missing required data
Target sample size

Research contact person
Name of lead principal investigator	1st name Johanes Middle name Last name Nugroho
Organization	Faculty of Medicine, Universitas Airlangga
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Jl. Mayjen Prof. Dr. Moestopo 47
TEL	6282139090953
Email	j.nugroho.eko@fk.unair.ac.id

Public contact
Name of contact person	1st name Johanes Middle name Last name Nugroho
Organization	Faculty of Medicine, Universitas Airlangga
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Jl. Mayjen Prof. Dr. Moestopo 47
TEL	6282139090953
Homepage URL
Email	j.nugroho.eko@fk.unair.ac.id

Sponsor
Institute	Faculty of Medicine, Universitas Airlangga
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Komite Etik Penelitian Kesehatan RSUD Dr Soetomo Surabaya
Address	Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel	0315501011
Email	kontak@rsudrsoetomo.jatimprov.go.id

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 05 Month 31 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	2000
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	Completed
Date of protocol fixation	2020 Year 05 Month 01 Day
Date of IRB	2020 Year 05 Month 02 Day
Anticipated trial start date	2020 Year 05 Month 10 Day
Last follow-up date	2020 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We perform this meta-analysis aims to determine the evidence-based relationship of D-Dimer with severity and mortality in SARS-CoV-2 patients A systematic search of all observational studies or trials that involving adult patients with SARS-CoV-2 that had any data D-dimer on admission for comparison severe vs non-severe; ICU vs non-ICU; survivor vs non-survivor was carried out using the PubMed, Science Direct and MedRxiv databases. Two authors independently assessed the methodological quality using the Risk of Bias Tool and employed the GRADE approach to evaluate the quality of evidence. We performed random-effects inverse-variance weighted meta-analysis of D-dimer values using RevMan 5.3. Manager (RevMan v5.3 2014).

Management information
Registered date	2020 Year 05 Month 18 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046143