UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044745 |
|---|---|
| Receipt number | R000050761 |
| Scientific Title | A prospective observational study to elucidate the dynamics of microparticles and their pathophysiological role in septic disseminated intravascular coagulation syndrome. |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/01/03 11:44:47 |
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Basic information
Public title
A prospective observational study to elucidate the dynamics of microparticles and their pathophysiological role in septic disseminated intravascular coagulation syndrome.
Acronym
A prospective observational study to elucidate the dynamics of microparticles and their pathophysiological role in septic disseminated intravascular coagulation syndrome.
Scientific Title
A prospective observational study to elucidate the dynamics of microparticles and their pathophysiological role in septic disseminated intravascular coagulation syndrome.
Scientific Title:Acronym
A prospective observational study to elucidate the dynamics of microparticles and their pathophysiological role in septic disseminated intravascular coagulation syndrome.
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the dynamics of Tissue Factor (TF) bearing microparticles involved in the progression of septic DIC.
Basic objectives2
Others
Basic objectives -Others
To understand the dynamics of MPs derived from endothelial cells, platelets, monocytes, and neutrophils, which are involved in the progression of septic DIC, and to verify the procoagulant effect of MPs derived from septic DIC patients by thromboelastography and thrombin generation test.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the amount of Tissue factor bearing microparticles (TF banding MPs) at the first blood draw in the DIC and non-DIC groups.
Key secondary outcomes
Comparison of the production of other MPs (monocyte-derived, endothelial cell-derived, platelet-derived, etc.) between DIC and non-DIC groups. Thrombin generation study.
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 with sepsis diagnosed by Sepsis-3 admitted to Tohoku University Hospital
Key exclusion criteria
1) Cases for which consent was not obtained from the patient or the patient's next of kin
2) Patients requiring mechanical assisted circulation (IABP, ECMO, LVAD)
3) Patients requiring acute blood purification therapy prior to the start of the study
4) Patients with infection more than 7 days prior to study enrollment or with unknown onset of infection
5) Pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Takei |
Organization
Tohoku University Hospital
Division name
department of Anesthesiology and preoperative medicine
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7321
yusuke.takei.a3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takei |
Organization
Tohoku University Hospital
Division name
department of Anesthesiology and preoperative medicine
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7321
Homepage URL
yusuke.takei.a3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
department of Anesthesiology and preoperative medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-7321
med-kenkyo@grp.tohoku.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
| 2021 | Year | 08 | Month | 01 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the dynamics of MPs in patients presenting with septic DIC compared with that without septic DIC.
Management information
Registered date
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050761
