UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039686 |
|---|---|
| Receipt number | R000045268 |
| Scientific Title | ExtraCorporeal Membrane Oxygenation for 2019 novel Coronavirus Acute Respiratory Disease |
| Date of disclosure of the study information | 2020/03/06 |
| Last modified on | 2023/03/07 10:36:17 |
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Basic information
Public title
ExtraCorporeal Membrane Oxygenation for 2019 novel Coronavirus Acute Respiratory Disease
Acronym
ECMOCARD Study
Scientific Title
ExtraCorporeal Membrane Oxygenation for 2019 novel Coronavirus Acute Respiratory Disease
Scientific Title:Acronym
ECMOCARD Study
Region
| Japan | Asia(except Japan) | Australia |
| Europe |
Condition
Condition
COVID-19
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe clinical features; severity of pulmonary dysfunction; incidence of ICU admission and use of mechanical ventilation and ECMO; ECMO technical characteristics; duration of ECMO; complications; and survival of patients with COVID-19.
Basic objectives2
Others
Basic objectives -Others
This is a multi-centre international study in patients with COVID-19 who require admission to the intensive care unit, mechanical ventilation and/or ECMO to characterize the following features:
1. Incidence of ICU admission, use of mechanical ventilation and ECMO
2. Risk factors
3. Clinical features
4. Severity of respiratory failure
5. Need for non-invasive and invasive mechanical ventilation and ECMO
6. ECMO technical characteristics
7. Duration of ECMO
8. Complications
9. ICU survival
10. Hospital survival.
11. Requirements and the time frame for approvals in each participating network region
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Date of ECMO discontinuation
2. Date of invasive mechanical ventilation discontinuation
3. Date of ICU Discharge
4. Date of Hospital Discharge
5. Mortality at 28 days
6. Main cause of death
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Laboratory-confirmed COVID-19 infection by real-time PCR and/or next-generation sequencing
2. Admission to an intensive care unit
Key exclusion criteria
1. Patients treated with mechanical ventilation for other concomitant causes
2. Patients treated with ECMO for other concomitant causes
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Ichiba |
Organization
Nippon Medical School
Division name
Department of Surgical Intensive Care
Zip code
113-8603
Address
Sendagi 1-1-5, Bunkyou-ku, Tokyo
TEL
03-3822-2131
ecmoshingo@gmail.com
Public contact
Name of contact person
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
Saiseikai Utsunomiya Hospital
Division name
Department of emergency medicine and intensive care unit
Zip code
321-0974
Address
Takebayashi 911-1, Utsunomiya-shi, Tochigi
TEL
028-626-5500
Homepage URL
keiliu0406@gmail.com
Sponsor or person
Institute
Critical Care Research Group
The Prince Charles Hospital
Institute
Department
Personal name
Funding Source
Organization
not availale
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Utsunomiya Hospital
Address
Takebayashi 911-1, Utsunomiya-shi, Tochigi
Tel
028-626-5500
hiromu_tsurumi@saimiya.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
| 2020 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.covid-critical.com/publications
Number of participants that the trial has enrolled
20000
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
| 2020 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
International multicenter observational study
19,000 patient registrations, 414 cooperating medical facilities in 63 countries (as of 5 September 2022)
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045268
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
