UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043459 |
|---|---|
| Receipt number | R000049628 |
| Scientific Title | Anticoagulation, Risk of Bleeding, and Overall mortality in Hospitalized Patients with COVID-19: A Meta-Analysis |
| Date of disclosure of the study information | 2021/02/27 |
| Last modified on | 2022/03/09 09:55:57 |
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Basic information
Public title
Anticoagulation, Risk of Bleeding, and Overall mortality in Hospitalized Patients with COVID-19: A Meta-Analysis
Acronym
Anticoagulation, Risk of Bleeding, and Overall mortality in Hospitalized Patients with COVID-19: A Meta-Analysis
Scientific Title
Anticoagulation, Risk of Bleeding, and Overall mortality in Hospitalized Patients with COVID-19: A Meta-Analysis
Scientific Title:Acronym
Anticoagulation, Risk of Bleeding, and Overall mortality in Hospitalized Patients with COVID-19: A Meta-Analysis
Region
| Asia(except Japan) |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
| Infectious disease | Anesthesiology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Due to the current equipoise surrounding pharmacologic thromboprophylaxis in hospitalized patients with COVID-19 coupled with maturing observational data in the field, We compared summary bleeding and mortality rates in hospitalized patients with COVID-19 stratified by anticoagulation dosing (none, standard dosage, intermediate dose, andfull therapeutic anticoagulation) to assess theimpact of anticoagulation on bleeding and mortality outcomes.
Basic objectives2
Others
Basic objectives -Others
This meta-analysis aimed to determine the theimpact of anticoagulation on bleeding and mortality outcomes of COVID-19
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bleeding rate in each anticoagulation dosing
Key secondary outcomes
Mortality rate in each anticoagulation dosing
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
all observational studies or trials involving adult patients with COVID-19 that had any data of anticoagulation use for comparison poor vs good outcome
Key exclusion criteria
missing required data, no data on anticoagulant use, no outcome of interest, other than english language
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Johanes |
| Middle name | |
| Last name | Nugroho |
Organization
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
6282139090953
j.nugroho.eko@fk.unair.ac.id
Public contact
Name of contact person
| 1st name | Eka |
| Middle name | Prasetya Budi |
| Last name | Mulia |
Organization
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
628562765365
Homepage URL
https://www.researchgate.net/profile/Eka_Mulia
eka.prasetya.budi-2017@fk.unair.ac.id
Sponsor or person
Institute
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
Komite Etik Penelitian Kesehatan RSUD Dr Soetomo, Surabaya, Indonesia
Address
Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel
62315501011
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
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 27 | 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
2506
Results
LMWH administration was associated with a lower in-hospital mortality, and 28/30-day mortality compared with UFH administration. However, there was no difference in the incidence of bleeding with LMWH compared with UFH.
Results date posted
| 2022 | Year | 03 | Month | 09 | Day |
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
| 2021 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 21 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 05 | Day |
Other
Other related information
We perform this meta-analysis aims to determine the evidence-based relationship of anticoagulation dosing with bleeding and mortality in COVID-19 patients
A systematic search of all observational studies or trials that involving adult patients with COVID-19 that had any data of anticoagulation for comparison poor vs good outcome was carried out using the PubMed, Science Direct, and MedRxiv databases. Two authors independently assessed the methodological quality using the NIH quality assessment to evaluate the quality of evidence. We performed random-effects inverse-variance weighted meta-analysis of Coagulation profiles values using RevMan 5.4. Manager (RevMan v5.4 2020) and Stata v.16
Management information
Registered date
| 2021 | Year | 02 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049628
