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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029760
Receipt No. 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

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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
Email 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
Email yousuke.jpn4035@gmail.com

Sponsor
Institute Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033994

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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