UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Efficacy and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta with standardized protocol; A prospective observational study
Title of the study (Brief title)	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	Yosuke Matsumura
Organization	Chiba University Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
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	Yosuke Matsumura
Organization	Chiba University Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 07 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033994