UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039242 |
|---|---|
| Receipt number | 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 | 2022/07/29 20:44:21 |
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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
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
twada1@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
N/A
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fcvm.2022.885406/full
Number of participants that the trial has enrolled
62
Results
Patients with MODS exhibited higher histone levels than those without MODS during the early phase of the post-resuscitation period.Severe endothelial injury and higher thrombin and plasmin generation were observed in the MODS group. Plasma levels of histones were positively correlated with those of soluble fibrin immediately after resuscitation and PIC 3 h after arriving at the hospital. This correlation was prominent in the patient population with MODS.
Results date posted
| 2022 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences in age, sex, or initial rhythm of the electrocardiogram between patients from the two groups. The frequencies of witnessing the onset of cardiac arrest and bystander CPR were comparable between groups. However, the non-MODS group had a significantly higher percentage of patients with cardiogenic cardiac arrests. The CPR duration was significantly longer in the MODS group
than in the non-MODS group. Patients in the MODS group exhibited a higher DIC score on day 1 and a higher APACHE II score than those in the non-MODS group. Furthermore, the hospital survival rate was significantly higher in the non-MODS group than in the MODS group.
Participant flow
Out of the 47 patients, 12 were excluded from the study. Among the excluded patients, 11 did not achieve return of spontaneous circulation. We also excluded one patient because the samples were not treated appropriately.
In the present study, we analyzed the final cohort of 35 patients.
The patients were divided into multiple organ dysfunction (MODS) (n = 15) and non-MODS (n=20) groups.
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044738
