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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039242
Receipt No. R000044738
Scientific Title Investigation of the relationship between innate immune responses and coagulofibrinolytic responses in patients with out-of-hospital cardiac arrest
Date of disclosure of the study information 2020/01/23
Last modified on 2020/07/26

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Basic information
Public title Investigation of the relationship between immune system and coagulation system in patient with cardiac arrest outside the hospital
Acronym Investigation of the relationship between immune responses and coagulation responses in patient with cardiac arrest outside the hospital
Scientific Title Investigation of the relationship between innate immune responses and coagulofibrinolytic responses in patients with out-of-hospital cardiac arrest
Scientific Title:Acronym Investigation of the relationship between innate immune responses and coagulofibrinolytic responses in patients with out-of-hospital cardiac arrest
Region
Japan

Condition
Condition Out-of-hospital cardiac arrest
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Danger-associated molecular patterns (DAMPs) such as histones cause the endothelial cell injury and the activation of neutrophil.
DAMPs cause hypercoagulation, dysfunction of anticoagulation system and inhibition of fibrinolysis.
DAMPs produce immunothrombosis depending on activated neutrophils and systemic inflammation causes disseminated intravascular coagulation (DIC).
Cardiac arrest and resuscitation, namely systemic ischemia an reperfusion cause the release of DAMPs.
The development of DIC in patients after cardiac arrest and resuscitation cause organ dysfunction, leading to poor outcome.

Based on the above reports, the purpose of this study is to prove the hypothesis that thrombin, which is produced by histones released after cardiac arrest and resuscitation is associated with the development of DIC, leading organ dysfunction and poor outcome.
Basic objectives2 Others
Basic objectives -Others Investigation of pathomechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Severity of organ dysfunction, assessed by Sequential Organ Failure Assessment (SOFA) score
Key secondary outcomes The levels of histone H3, interleukin-6, and various markers of coagulation and fibrinolysis
Outcome (organ dysfunction, 28-days mortality and hospital death)
Impact of DIC on outcome

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 are 20 years of age or older at the time of obtaining consent
Patients who died without return of spontaneous circulation after out-of-hospital cardiac arrest
Patients who get return of spontaneous circulation
Investigators have to get informed consent from the patients or their legal authorized representatives after explaining the participation in this study to them and confirming their understanding.
Key exclusion criteria Patients with cardiac arrest due to trauma, acute aortic dissection or ruptured aortic aneurysm
Patients who take anticoagulants
Patients with coagulofibrinolytic disorders as underlying diseases
Other patients who are judged inappropriate by the principal investigator
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name WADA
Organization Hokkaido University Hospital
Division name Department of Emergency Medicine
Zip code 060-8648
Address Kita-ku, N14W15, Sapporo
TEL 011-706-7377
Email twada1@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name WADA
Organization Hokkaido University Hospital
Division name Department of Emergency Medicine
Zip code 060-8648
Address Kita-ku, N14W15, Sapporo
TEL 011-706-7377
Homepage URL
Email twada1@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JP

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Division of Clinical Research Administration, Hokkaido University Hospital
Address Kita-ku, N14W5, Sapporo
Tel 0117067636
Email 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
2020 Year 01 Month 23 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
2018 Year 06 Month 04 Day
Date of IRB
2018 Year 06 Month 22 Day
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measurement items
Histone H3, IL6, activated protein C, soluble fibrin, plasmin antiplasmin complex, soluble thrombomodulin, tPA activity, PAI1 activity

Observation items and its implementation methods
Researchers investigate the following items in patient group and use the data for this study. These are all items which are performed in daily clinical practice, and their frequency is equivalent to that in daily clinical practice.

Basic information of the objectives in this study. age, gender, weight, height, body temperature, blood pressure, pulse rate, respiratory rate, urine volume, medical past history, underlying disease, surgery, treatment, and 28 days or hospital outcome
Hematology. Ht, white blood cell counts, platelet counts
Blood biochemical tests. total bilirubin, creatinine, Na, K
Coagulation and fibrinolysis test. PT, fibrinogen, FDP, D dimer
Blood gas test. pH, PaO2, PaCO2, BE, HCO3
Various scores. APACHEII, SOFA, SIRS, DIC

Management information
Registered date
2020 Year 01 Month 23 Day
Last modified on
2020 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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