UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041428 |
|---|---|
| Receipt number | R000046671 |
| Scientific Title | Elevated fibrinogen and fibrin degradation product were associated with poor outcome in COVID-19 patients |
| Date of disclosure of the study information | 2020/08/16 |
| Last modified on | 2021/02/27 23:25:51 |
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Basic information
Public title
Elevated fibrinogen and fibrin degradation product were associated with poor outcome in COVID-19 patients
Acronym
Elevated fibrinogen and fibrin degradation product were associated with poor outcome in COVID-19 patients
Scientific Title
Elevated fibrinogen and fibrin degradation product were associated with poor outcome in COVID-19 patients
Scientific Title:Acronym
Elevated fibrinogen and fibrin degradation product were associated with poor outcome in COVID-19 patients
Region
| Asia(except Japan) |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many studies have shown that several laboratory parameters were related to poor outcome in COVID-19 patients. Thrombosis and coagulopathy often complicated in the course of those patients. Coagulation parameters including fibrinogen and FDP may become prognostic factors in COVID-19.
Basic objectives2
Others
Basic objectives -Others
This meta-analysis aimed to determine the relationship between fibrinogen and FDP with poor outcome in COVID-19 patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elevated fibrinogen and FDP level on admission were associated with an increase risk of poor outcomes in COVID-19 patients.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
year of publication, location, study design, peer-reviewed publication status, severity measurement, and fibrinogen and FDP level in each comparison group
Key exclusion criteria
1 incorrect patient population; 2: not reported relevant exposure (coagulation profile not available) 3: not reported relevant outcomes; 4 : review; 5: editorial; 6: duplicate; 7: case report; 8: not in english
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Johannes |
| Middle name | |
| Last name | Nugroho |
Organization
Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name
Department of Cardiology and Vascular Medicine
Zip code
60285
Address
Jl. Prof. Dr. Moestopo 47 Surabaya
TEL
6282139090953
j.nugroho.eko@fk.unair.ac.id
Public contact
Name of contact person
| 1st name | Maya |
| Middle name | Qurota |
| Last name | Ayun |
Organization
Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya
Division name
Department of Cardiology and Vascular Medicine
Zip code
60285
Address
Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Airlangga, Dr. Soeto
TEL
6281262208630
Homepage URL
maya.qurota.ayun-2019@fk.unair.ac.id
Sponsor or person
Institute
Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Address
Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Airlangga, Dr. Soetomo General Hospital, Surabaya, 60285, Indonesia
Tel
62315020251
info@fk.unair.ac.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
Universitas Airlangga
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
DOI: 10.3233/CH-200978
Number of participants that the trial has enrolled
1654
Results
A total of 17 studies (1.654 patients) were included in this meta-analysis. It revealed a higher mean of fibrinogen levels on admission in patients with severe case when compared to non-severe case. Non-survivor group had a pooled higher mean difference of fibrinogen values on admission. Higher FDP on admission was found in poor outcome (composite of severity, critically ill, and mortality) compared to good outcome.
Results date posted
| 2020 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 13 | Day |
Baseline Characteristics
Fifteen studies were retrospective, and two studies were prospective observational. Ten studies have already been undergone peer review. Most of the studies classified the severity according to the National Health Commission of Peoples Republic of China.
Participant flow
Adverse events
Outcome measures
a higher mean of fibrinogen levels on admission in patients with severe case when compared to non-severe case (MD = 0.69,[95%CI: 0.44 to 0.94], p <0.05; I2 = 72%, p <0.05). Non-survivor group had a pooled higher mean difference of fibrinogen values on admission (MD = 0.48[95% CI: 0.13 to 0.83], p<0.05; I2 = 38%, p=0.18). Higher FDP on admission was found in poor outcome (composite of severity, critically ill, and mortality) compared to good outcome (4 studies, MD = 4.84[95% CI: 0.75 to 8.93], p<0.05; I2 = 86%, p<0.05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
A systematic search of the literature was carried out on May 15, 2020, after receiving approval from the Institutional Review Board. Five different databases (PubMed, Science Direct, Scopus, ProQuest, and MedRxiv) were used to perform a systematic search.
Management information
Registered date
| 2020 | Year | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046671
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