UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046003 |
|---|---|
| Receipt number | R000052510 |
| Scientific Title | Prevalence of thrombotic complications in hospitalized COVID-19 patients in a medical ward in Japan: A single-center observational study |
| Date of disclosure of the study information | 2021/11/07 |
| Last modified on | 2023/10/14 19:37:40 |
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Basic information
Public title
Prevalence of thrombotic complications in hospitalized COVID-19 patients in a medical ward in Japan: A single-center observational study
Acronym
Prevalence of thrombotic complications in hospitalized COVID-19 patients in a medical ward in Japan: A single-center observational study
Scientific Title
Prevalence of thrombotic complications in hospitalized COVID-19 patients in a medical ward in Japan: A single-center observational study
Scientific Title:Acronym
Prevalence of thrombotic complications in hospitalized COVID-19 patients in a medical ward in Japan: A single-center observational study
Region
| Japan |
Condition
Condition
Infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the incidence of thrombotic complications among hospitalized COVID-19 patients in a medical ward in Japan
Basic objectives2
Others
Basic objectives -Others
To determine the incidence of thrombotic complications among hospitalized COVID-19 patients according to the worst severity of COVID-19 or Padua score at admission (0-3 points versus more or 4 points).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was any thrombotic complication, which included venous thromboembolism, myocardial infarction, ischemic stroke, and other arterial embolisms.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were symptomatic and had diagnoses confirmed by nucleic acid tests or antigen tests for SARS-CoV-2 were eligible.
Key exclusion criteria
1)Asymptomatic COVID-19 patients.
2)Clinically diagnosed COVID-19 patients who were not confirmed by tests for SARS-CoV-2.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Internal Medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL
028-622-5241
jkomagamine@tochigi-mc.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Fukuda |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Management Department
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL
028-622-5241
Homepage URL
fukuda.naoto.hw@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Tochigi Medical Center
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
National Hospital Organization Tochigi Medical Center
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
Tel
028-622-5241
torumed3@gmail.com
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
| 2021 | Year | 11 | Month | 07 | 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
1116
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
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center observational study was conducted to determine the prevalence of thrombotic complications in symptomatic COVID-19 patients in a medical ward. All consecutive COVID-19 patients who were admitted to our hospital from November 1, 2020, to October 26, 2021, were included.
Management information
Registered date
| 2021 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052510
