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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048610
Receipt No. R000055377
Scientific Title Primary Definitive Surgery for Hemorrhage in Hepatic Injury with Unstable Hemodynamics:
Date of disclosure of the study information 2022/08/06
Last modified on 2022/08/06

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Basic information
Public title Primary Definitive Surgery for Hemorrhage in Hepatic Injury with Unstable Hemodynamics:
Acronym Primary Definitive Surgery for Hemorrhage in Hepatic Injury with Unstable Hemodynamics:
Scientific Title Primary Definitive Surgery for Hemorrhage in Hepatic Injury with Unstable Hemodynamics:
Scientific Title:Acronym Primary Definitive Surgery for Hemorrhage in Hepatic Injury with Unstable Hemodynamics:
Region
Japan

Condition
Condition hemodynamically unstable patients with severe hepatic injury requiring surgical interventions for massive hemoperitoneum
Classification by specialty
Surgery in general Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We hypothesized that definitive surgery (DS) improves the long and short-term outcomes of hepatic injury with hemodynamic instability requiring expeditious hemorrhagic control, compared with DCS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30-day mortality
Key secondary outcomes 48-hour mortality and morbidity

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Primary definitive surgery (DS) group
Interventions/Control_2 Damage control surgery (DCS) group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with severe hepatic injury requiring surgical intervention for massive hemoperitoneum
Key exclusion criteria Patients with hemodynamic stability, mild hemoperitoneum, additional perihepatic packing, untreatable malignancy, and cardiopulmonary arrest on arrival were excluded.
Target sample size 368

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Matsuda
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Emergency and Critical Care Medicine
Zip code 3508550
Address 1981 Kamoda, Kawagoe City, Saitama
TEL +81-49-228-3400
Email godfather5522@gmail.com

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Matsuda
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Emergency and Critical Care Medicine
Zip code 3508550
Address 1981 Kamoda, Kawagoe City, Saitama
TEL +81-49-228-3400
Homepage URL
Email godfather5522@gmail.com

Sponsor
Institute Department of Emergency and Critical Care Medicine, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Emergency and Critical Care Medicine, Saitama Medical Center, Saitama Medical University
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 The Institutional Review Board of Saitama Medical University
Address 1981 Kamoda, Kawagoe City, Saitama
Tel +81-49-228-3400
Email smcrinri@saitama-med.ac.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

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 368
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 Completed
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
2021 Year 04 Month 22 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 06 Day
Last modified on
2022 Year 08 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055377

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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