UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006714 |
|---|---|
| Receipt number | R000007937 |
| Scientific Title | Role of damage-associated molecular patterns (DAMPs) in the pathophysiology of systemic inflammation, coagulation, and immune status in citically ill patients: A prospective, single center, clinical study |
| Date of disclosure of the study information | 2011/11/14 |
| Last modified on | 2011/11/13 12:47:15 |
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Basic information
Public title
Role of damage-associated molecular patterns (DAMPs) in the pathophysiology of systemic inflammation, coagulation, and immune status in citically ill patients: A prospective, single center, clinical study
Acronym
Role of DAMPs in citically ill patients: A prospective study
Scientific Title
Role of damage-associated molecular patterns (DAMPs) in the pathophysiology of systemic inflammation, coagulation, and immune status in citically ill patients: A prospective, single center, clinical study
Scientific Title:Acronym
Role of DAMPs in citically ill patients: A prospective study
Region
| Japan |
Condition
Condition
Trauma, burn, sepsis, rhabdomyolysis and post-cardiac arrest syndrome
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the role of DAMPs in the pathophysiology of systemic inflammation, coagulation, and immune status in citically ill patients
Basic objectives2
Others
Basic objectives -Others
Clinical condition elucidation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the relationship between DAMPs and systemic inflammatory, coagulo-fibrinolytic, innate immune status
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
Trauma;having one or more injuries ofAIS >3
Burn;TBSA >10%
Sepsis;severe sepsis, septic shock
Rhabdomyolysis ;CK >5,000 IU/L
Postcardiac arrest syndrome
Key exclusion criteria
Patients without the consent of himself, his legal representative nor guardian.
Attending physician's decision for inappropriateness for inclusion
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamanouchi |
Organization
Tohoku University School of Medicine
Division name
Division of Emergency Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University School of Medicine
Division name
Division of Emergency Medicine
Zip code
Address
TEL
022-717-7489
Homepage URL
Sponsor or person
Institute
Division of Emergency Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2011 | Year | 11 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective, single center, clinical study
Management information
Registered date
| 2011 | Year | 11 | Month | 13 | Day |
Last modified on
| 2011 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007937
