UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050840 |
|---|---|
| Receipt number | R000057939 |
| Scientific Title | Potential Harms of Emergency Department Thoracotomy in Patients With Persistent Cardiac Arrest Following Trauma: A Nationwide Observational Study |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2023/10/12 09:47:41 |
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Basic information
Public title
Potential Harms of Emergency Department Thoracotomy in Patients With Persistent Cardiac Arrest Following Trauma: A Nationwide Observational Study
Acronym
EDT for Persistent Traumatic Cardiac Arrest
Scientific Title
Potential Harms of Emergency Department Thoracotomy in Patients With Persistent Cardiac Arrest Following Trauma: A Nationwide Observational Study
Scientific Title:Acronym
EDT for Persistent Traumatic Cardiac Arrest
Region
| Japan |
Condition
Condition
Persistent traumatic cardiac arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aimed to elucidate the balance between the benefits and harms of emergency department thoracotomy for patients with persistent traumatic out-of-hospital cardiac arrest.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival to discharge
Key secondary outcomes
Days of ventilator use, length of ICU and hospital stay, frequencies of emergency hemostatic procedures, including surgery, angiography, and REBOA, and the amount of transfusion, including red blood cells, fresh frozen plasma, and platelets
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Trauma patients (1) aged older than or equal to 18 years, (2) with no measurable blood pressure at the scene and (3) on hospital arrival, which is defined as 0 mmHg of systolic blood pressure on arrival,
Key exclusion criteria
Patients with missing data on survival at discharge
Target sample size
1289
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0332251323
ryo.yamamoto@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0332251323
Homepage URL
ryo.yamamoto@gmail.com
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Keio University School of Medicine
Institute
Department
Personal name
Ryo Yamamoto
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
Keio University School of Medicine Institutional Review Board
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
0332251323
med-rinri-jimu@adst.keio.ac.jp
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
| 2023 | Year | 04 | Month | 13 | 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
1289
Results
Survival to discharge was significantly lower among patients treated with Emergency Department Thoracotomy (EDT) than among those without EDT (1.0% vs. 2.2%; OR: 0.43; p = 0.011).
Results date posted
| 2023 | Year | 04 | Month | 13 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057939
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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