UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035458 |
|---|---|
| Receipt number | R000038919 |
| Scientific Title | Prospective observational study on the effectiveness and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in traumatic shock patients due to torso hemorrhage |
| Date of disclosure of the study information | 2019/01/06 |
| Last modified on | 2024/01/09 09:05:56 |
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Basic information
Public title
Prospective observational study on the effectiveness and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in traumatic shock patients due to torso hemorrhage
Acronym
Effectiveness of REBOA in traumatic shock
Scientific Title
Prospective observational study on the effectiveness and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in traumatic shock patients due to torso hemorrhage
Scientific Title:Acronym
Effectiveness of REBOA in traumatic shock
Region
| Japan | Asia(except Japan) |
Condition
Condition
traumatic hemorrhagic shock patients
Classification by specialty
| Surgery in general | Radiology | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will prospectively register traumatic shock patients due to torso hemorrhage who is judged to require hemostasis (surgery and/or interventional radiology) and adjust the heterogeneity of the subjects. We aim to evaluate the relationship between REBOA use and survival outcome using propensity score matching.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
Secondary endpoints include presence or absence of hemorrhagic death judged by the attending physician, blood transfusion requirement within first 24 hours, complications (systemic complications, device-related complications, and vascular access-related complications), ICU-free days and ventilator free days of 28 days after hospitalization.
Complications and their outcomes are defined as follows:
Systemic complications: renal dysfunction (with or without renal replacement therapy), intestinal ischemia (presence or absence of intestinal necrosis by contrast CT or surgery), cerebral infarction (nerve dropout findings such as new onset hemiplegia and image findings), spinal cord infarction (limb paralysis or paralysis), aortic injury (X-ray or CT, angiography or judgment by attending physician)
Device-related complications: catheter position abnormality (presence or absence of indwelling in an unintended vessel), presence or absence of balloon migration (downstream movement of the balloon with less pressure increase than expected), presence or absence of balloon rupture
Access-related complications: vascular dissection, pseudoaneurysm (repair surgery or intravascular treatment), puncture hematoma, retroperitoneal hematoma (required hemostasis procedure), thromboembolism, vascular stenosis (thrombectomy, angioplasty, or surgical operation), lower limb ischemia (fasciotomy or lower limb amputation)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Traumatic shock patients due to torso hemorrhage who is judged to require hemostasis (surgery and/or interventional radiology)
Baseline is defined as arrival or contact with medical team
Include only those patients whose doctor decided to stop bleeding within 60 minutes of arrival or contact with medical team (*not to start hemostasis)
Include multiple injuries regardless of head injury
Age of16 years and over (estimated weight 40 kg or more when age is unknown).
Key exclusion criteria
Cardiac arrest before contact with physician
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, 260-8677, Japan
TEL
0432227171
odas@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, 260-8677, Japan
TEL
0432227171
Homepage URL
yousuke.jpn4035@gmail.com
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hspital/Japanese Assciation for the Surgery of Trauma
Address
1-8-1, Inohana, Chuo-ku, Chiba city
Tel
0432227171
y-ohashi@office.chiba-u.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/12/4/e053743
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to COVID-19
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
The protocol paper
https://bmjopen.bmj.com/content/12/4/e053743
Management information
Registered date
| 2019 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038919
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