UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061821 |
|---|---|
| Receipt number | R000070739 |
| Scientific Title | Burn Outcome, SOFA, and Sepsis/Microbiology Registry: A Collaborative Retrospective Cohort |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/08 23:30:19 |
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Basic information
Public title
The Relationship Between Various Factors and Prognosis in Patients with Severe Burns
Acronym
The Relationship Between Various Factors and Prognosis in Patients with Severe Burns
Scientific Title
Burn Outcome, SOFA, and Sepsis/Microbiology Registry: A Collaborative Retrospective Cohort
Scientific Title:Acronym
BOSS-Burn Study
Region
| Japan |
Condition
Condition
Severe burn
Classification by specialty
| Dermatology | Plastic surgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the relationship between organ failure and coagulation disorders during the acute phase of severe burn injury and their impact on prognosis.
Basic objectives2
Others
Basic objectives -Others
We aim to investigate the relationship between trends in wound culture results and patient prognosis during the acute phase of severe burn injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Relationship Between SOFA Scores and Survival Outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study includes patients with severe burns admitted to participating institutions between January 1, 2020, and December 31, 2024.
1. Patients aged 18 years or older at the time of admission to each facility;
2. Patients transported directly from the site of injury or admitted within 3 days of injury;
3. Patients with a %TBSA (total body surface area burned, combining second- and third-degree burns) of 20% or more;
4. Patients who have not expressed refusal to participate in this study.
Key exclusion criteria
1. Specialized burns (e.g., chemical burns, electrical burns)
2. Complications associated with injuries rated 3 or higher on the Abbreviated Injury Scale (AIS)
3. Complications associated with cardiac arrest prior to arrival
4. Any other individuals deemed unsuitable as study participants by the principal investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kunihiko |
| Middle name | |
| Last name | Maekawa |
Organization
Hokkaido university hospital
Division name
Emergency and critical care center
Zip code
060-8648
Address
Kita-ku, N14W5, Spporo
TEL
011-706-7377
gateofzen@gmail.com
Public contact
Name of contact person
| 1st name | Mineji |
| Middle name | |
| Last name | Hayakawa |
Organization
Sapporo City General Hospital
Division name
Department of Emergency and General Medicine
Zip code
060-8604
Address
Chuou-Ku, N11W13 1-1
TEL
011-726-2277
Homepage URL
mineji@dream.com
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita-ku, N14W5, Spporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2026 | Year | 06 | Month | 08 | 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
174
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will conduct a survey on the following items and use the resulting data in this study. All of these items are routinely collected during daily clinical practice, and the frequency of data collection is equivalent to that in routine clinical practice. We will use clinical data up to December 31, 2025.
1. Basic information on study participants: age, gender, underlying medical conditions
2. Burn-related information: mechanism of injury, date and time of injury, date and time of admission, burn type, percentage of body surface area (% BSA) with second-degree burns, percentage of body surface area (% BSA) with third-degree burns
3. Blood laboratory tests: Hemoglobin, white blood cell count, platelet count, PT-INR, APTT, fibrinogen, D-dimer, FDP, AT activity, total bilirubin, albumin, AST, ALT, CK, LDH, BUN, creatinine, blood gas analysis results (items underlined are measured only at admission; others are measured up to day 7 after admission)
4. SOFA score (Organ Failure Score) (up to Day 7 after admission)
5. Culture results from burn wounds (up to Day 21 after admission)
6. Number of days on mechanical ventilation (up to Day 28 after admission), blood transfusion volume (up to Day 7 after admission)
7. Date of debridement/skin grafting (up to Day 28 after admission)
8. Use of antithrombin agents (up to Day 7 after admission)
9. Date of discharge, prognosis at discharge, and, if treatment was discontinued, the date of that decision and the reason
Management information
Registered date
| 2026 | Year | 06 | Month | 07 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070739
