UMIN-CTR Clinical Trial

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
Email	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
Email	eka.prasetya.budi-2017@fk.unair.ac.id

Sponsor
Institute	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049628