UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050355 |
|---|---|
| Receipt number | R000057272 |
| Scientific Title | Coagulation assessment of Antithrombin preparations in disseminated intravascular coagulation syndrome (DIC) associated with pneumonia. |
| Date of disclosure of the study information | 2023/02/16 |
| Last modified on | 2025/02/17 12:48:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Coagulation assessment of Antithrombin preparations in disseminated intravascular coagulation syndrome (DIC) associated with pneumonia.
Acronym
Coagulation assessment of AT preparations in DIC associated pneumonia
Scientific Title
Coagulation assessment of Antithrombin preparations in disseminated intravascular coagulation syndrome (DIC) associated with pneumonia.
Scientific Title:Acronym
Coagulation assessment of AT preparations in DIC associated pneumonia
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the coagulation in Antithrombin preparations for DIC associated pneumonia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transition in coagulation fibrinolysis markers, inflammatory cytokines, vascular endothelial markers and AT during the first 5 days after administration of AT preparations
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
1:Patients with sepsis due to pneumonia (including septic shock) and with an acute DIC criteria of at least 4 points.
2:Age is 20 years or older at the time of case registration.
3:AT activity level less than 70%.
4:Written informed consent has been obtained from the study subjects themselves or their surrogates.
Key exclusion criteria
1:Patients with any of the following.
(i) Complicated non-compensated liver cirrhosis with a Child-Pugh score of Grade B or above.
(ii) Leukemia and related diseases.
(iii) Patients with malignant tumors and receiving chemotherapy
2:Acute stage of trauma and burn injury
3:Patients receiving concomitant use of recombinant thrombomodulin
4:Patients on hemodialysis or extracorporeal circulation (CHDF, ECMO)
5:Research subjects who are judged by the principal investigator or physician in charge to be unsuitable for the safe conduct of this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
+81-72-683-1221
kazuma.yamakawa@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Hisamune |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
+81-72-683-1221
Homepage URL
ryo.hisamune@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Kazuma Yamakawa
Funding Source
Organization
Japan blood product organization
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi, Takatsuki, Osaka
Tel
+81-72-683-1221
ryo.hisamune@ompu.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
| 2023 | Year | 02 | Month | 16 | 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
| 2022 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 20 | 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
Drug: Antithrombin gamma (genetically modified),Volume: 36IU/kg, Times: 3 times generally
<Inclusion>
only adult(over 20 years old)
1:Patients with sepsis due to pneumonia (including septic shock) and with an acute DIC criteria of at least 4 points.
2:Age is 20 years or older at the time of case registration.
3:AT activity level less than 70%.
4:Written informed consent has been obtained from the study subjects themselves or their surrogates.
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057272
