UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029760 |
|---|---|
| Receipt number | R000033994 |
| Scientific Title | Evaluation of Efficacy and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta with standardized protocol; A prospective observational study |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/10/31 13:10:26 |
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Basic information
Public title
Evaluation of Efficacy and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta with standardized protocol; A prospective observational study
Acronym
Efficacy and Safety of Standardized REBOA protocol
Scientific Title
Evaluation of Efficacy and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta with standardized protocol; A prospective observational study
Scientific Title:Acronym
Efficacy and Safety of Standardized REBOA protocol
Region
| Japan |
Condition
Condition
Refractory hemorrhagic shock
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
REBOA protocol will be introduced to multicenter to standardize the indication and management based on previous studies. The objective of this study
is to evaluate the efficacy and safety of REBOA with standardized protocol in a prospective observational study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24 hour and 30 day mortality
Transfusion within first 24 hours
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Refractory hemorrhagic shock undergoing REBOA
Key exclusion criteria
Age <15 years old
The patients undergoing resuscitative thoraacotomy, elective cases, REBOA catheter placement without inflation
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Matsumura |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, 260-8677, Japan
TEL
043-222-7171
yousuke.jpn4035@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Matsumura |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, 260-8677, Japan
TEL
043-222-7171
Homepage URL
yousuke.jpn4035@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine
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
Address
Tel
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
| 2018 | Year | 01 | Month | 01 | 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
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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients: Refractory hemorrhagic shock (or suspected) patients undergoing REBOA catheter placement
Exposure: Occlusion duration <30 minutes
Comparison: Occlusion duration >30 minutes
Outcome: 24-hour and 30-day mortality, transfusion within 24 hours
Evaluation: Previous study revealed 24-hour non-survivors showed lower preocclusion SBP (40 vs 70 mmHg) and prolonged occlusion duration (60 vs 30 minutes). Based on this data and other clinical consensus, we suggested REBOA protocol to participating hospitals.
Measurements
1. Demographics age, sex, indication
2. Placement method (fluoroscpy ultrasound, blind, cutdown), guidewire confirmation
3.Occlusion effect (pre- and post-occlusion pressure)
4.Occlusion duration and partial occlusion
5. Time to definitive hemostasis
6. Complication (access-related, systemic)
7. Outcome (24-hour and 30-day mortality, 24-hour transfusion)
Management information
Registered date
| 2017 | Year | 10 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033994
| 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 |
