UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048610 |
|---|---|
| Receipt number | 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 07:42:58 |
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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
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
godfather5522@gmail.com
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055377
