UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058157 |
|---|---|
| Receipt number | R000066472 |
| Scientific Title | A Retrospective Observational Study Investigating the Association Between Platelet Morphology and Clinical Outcomes in Patients with Sepsis |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/12 10:52:39 |
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Basic information
Public title
A Retrospective Observational Study Investigating the Association Between Platelet Morphology and Clinical Outcomes in Patients with Sepsis
Acronym
A Retrospective Observational Study Investigating the Association Between Platelet Morphology and Clinical Outcomes in Patients with Sepsis
Scientific Title
A Retrospective Observational Study Investigating the Association Between Platelet Morphology and Clinical Outcomes in Patients with Sepsis
Scientific Title:Acronym
A Retrospective Observational Study Investigating the Association Between Platelet Morphology and Clinical Outcomes in Patients with Sepsis
Region
| Japan |
Condition
Condition
Sepsis-induced disseminated intravascular coagulation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with sepsis frequently develop sepsis-induced disseminated intravascular coagulation (DIC). Platelets play an essential role in forming immunothrombi that localize exogenous pathogens. However, in DIC, the coagulation process becomes dysregulated, resulting in a pathological hypercoagulable state. Excessive microthrombus formation impairs systemic organ perfusion and contributes to multiple organ dysfunction. Therefore, platelets are critical for the management of DIC and are widely utilized as indicators for both diagnosis and therapeutic monitoring. Inflammatory conditions such as infection lead to increased platelet consumption and production, causing significant alterations in morphological indices, including mean platelet volume (MPV) and platelet distribution width (PDW). We hypothesize that these morphological changes are associated with prognosis and treatment response in patients with sepsis-induced DIC. To test this hypothesis, we conducted a retrospective observational study.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between platelet morphology and mortality in patients with sepsis-induced disseminated intravascular coagulation requiring therapeutic intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day, 90-day, and in-hospital mortality
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with sepsis-induced disseminated intravascular coagulation and received treatment"
Key exclusion criteria
Patients who received treatment outside of the intensive care unit
Patients with disseminated intravascular coagulation not attributable to sepsis
Patients deemed unsuitable for inclusion in the study by the principal investigator or study staff for any other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
TEL
0534352738
suzukiy@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
TEL
0534352738
Homepage URL
suzukiy@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Suzuki
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
Tel
0534352680
rinri@hama-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
静岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, retrospective observational study. We will include patients admitted to the ICU with a diagnosis of sepsis-induced DIC between January 2020 and April 2024. Platelet morphological indices (MPV, PDW) will be extracted from medical records and analyzed in relation to clinical outcomes such as mortality.
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066472
