UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053785 |
|---|---|
| Receipt number | R000061386 |
| Scientific Title | Adjunctive vasopressor use in trauma patients with hemorrhagic shock. |
| Date of disclosure of the study information | 2024/03/06 |
| Last modified on | 2024/03/06 09:11:55 |
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Basic information
Public title
Adjunctive vasopressor use in trauma patients with hemorrhagic shock.
Acronym
Vasopressor use in trauma patients with hemorrhagic shock.
Scientific Title
Adjunctive vasopressor use in trauma patients with hemorrhagic shock.
Scientific Title:Acronym
Adjunctive vasopressor use in trauma patients with hemorrhagic shock.
Region
| Japan |
Condition
Condition
Trauma patients with hemorrhagic shock (suspected)
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effectiveness of early administer of vasopressors for the trauma patients with hemorrhagic shock
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exsanguination at 24 hours after intervention
Key secondary outcomes
1. Total amount of transfusion and infusion volume
2. Incidence rates of adverse events (arrhythmia, thrombosis, ischemia, or hemorrhage) during the 72 hours after intervention
3. All-cause mortality rate at 28 days
4. Ventilator-free days at 28 days after intervention
5. All-cause mortality at 90 days after intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Early administration of vasopressor
Interventions/Control_2
Conventional treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with trauma who suffered hemorrhagic shock (suspected)
Key exclusion criteria
1. Patients with prehospital cardiac arrest
2. Patients who have been on vasopressors at other hospital
3. Patients who refuse to participate in the trial
4. Patients deemed ineligible to participate by a clinical physician
5 .Patients who have the advanced directives restricting implementation of the standard critical care
Target sample size
850
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Takayama |
Organization
Tokyo Medical and Dental University
Division name
Tokyo Medical and Dental University Department of Acute Critical Care and Disaster Medicine, Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
tak2accm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Takayama |
Organization
Tokyo Medical and Dental University
Division name
Tokyo Medical and Dental University Department of Acute Critical Care and Disaster Medicine, Graduat
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
tak2accm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Trauma and Acute Critical Care Center
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-6111
tak2accm@tmd.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
| 2024 | Year | 03 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061386
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
