UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050170 |
|---|---|
| Receipt number | R000057146 |
| Scientific Title | Treatments for trauma-induced coagulopathy: a protocol for systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/01/29 |
| Last modified on | 2024/02/04 23:05:22 |
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Basic information
Public title
Treatments for trauma-induced coagulopathy: a protocol for systematic review and meta-analysis
Acronym
Treatments for trauma-induced coagulopathy: a protocol for systematic review and meta-analysis
Scientific Title
Treatments for trauma-induced coagulopathy: a protocol for systematic review and meta-analysis
Scientific Title:Acronym
Treatments for trauma-induced coagulopathy: a protocol for systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Trauma-induced coagulopathy
Classification by specialty
| Surgery in general | Laboratory medicine | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of clotting factor replacement and other treatments in patients with traumatic coagulopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in-hospital mortality due to all causes
Key secondary outcomes
the quantity of the transfused blood within 24 hours, blood loss within 24 hours, thrombotic events (i.e., deep venous thromboses, pulmonary embolization, myocardial infarctions, strokes), multiple organ failures.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will include severe trauma patients with TIC admitted to the hospital. TIC is defined as abnormal of FIBTEM, depletion of fibrinogen or each studies defined as TIC. We will not restrict our review by country.
Key exclusion criteria
Non-traumatic patients and trauma patients without coagulopathy
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Itagaki |
Organization
Hokkaido University Hospital
Division name
Department of Emergency Medicine,
Zip code
060-8638
Address
kita15, nishi 7, kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7377
koaraninaritaizo@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Itagaki |
Organization
Hokkaido university hospital
Division name
Department of emergency medicine
Zip code
060-8638
Address
kita15, nishi 7, kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7377
Homepage URL
koaraninaritaizo@gmail.com
Sponsor or person
Institute
Department of Emergency Medicine, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Emergency Medicine, Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Scientific and Standardization Committee on DIC of the Japanese Society on Thrombosis and Hemostasis
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Emergency Medicine, Hokkaido University Hospital
Address
kita15, nishi 7, kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7377
koaraninaritaizo@gmail.com
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
Department of Emergency Medicine, Hokkaido University Hospital
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 29 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 10 | Day |
Other
Other related information
To examine the effects of clotting factors, platelets, and tranexamic acid administered to severe trauma patients with coagulation disorders.
Management information
Registered date
| 2023 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057146
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
