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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035458
Receipt No. R000038919
Official scientific title of the study 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 2019/01/05

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Basic information
Official scientific title of the study 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
Title of the study (Brief title) 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 Shigeto Oda
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 0432227171
Email odas@faculty.chiba-u.jp

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 0432227171
Homepage URL
Email yousuke.jpn4035@gmail.com

Sponsor
Institute Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 31 Day
Anticipated trial start date
2019 Year 04 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 Prospective observational study

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038919

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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