UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041854 |
|---|---|
| Receipt number | R000047778 |
| Scientific Title | Efficacy and safety of prehospital administration of tranexamic acid (TXA) for trauma patients |
| Date of disclosure of the study information | 2020/09/21 |
| Last modified on | 2023/04/09 19:21:35 |
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Basic information
Public title
Efficacy and safety of prehospital administration of tranexamic acid (TXA) for trauma patients
Acronym
Efficacy and safety of prehospital administration of tranexamic acid (TXA) for trauma patients
Scientific Title
Efficacy and safety of prehospital administration of tranexamic acid (TXA) for trauma patients
Scientific Title:Acronym
Efficacy and safety of prehospital administration of tranexamic acid (TXA) for trauma patients
Region
| Japan |
Condition
Condition
Trauma
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a treatment for trauma patients by early TXA administration, we will administer TXA to trauma patients transported by the doctor car or the helicopter in prehospital settings, and confirm the efficacy and safety of TXA administration based on the clinical course and outcome of the patients. In addition, we will examine the efficacy of TXA administration in prehospital settings based on the changes in coagulation fibrinolytic parameters and elucidate the pathogenesis of coagulation fibrinolytic disorders associated with trauma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality at 28 days
Key secondary outcomes
mRS at 3 months, volume of transfusion, coagulation fibrinolytic parameters (prothrombin time (PT), activated partial thromboplastin time (aPTT), Fibrinogen, thrombin-antithrombin complex (TAT), FDP, D-dimer, alpha 2 plasmin inhibitor (alpha 2-PI), plasmin-alpha 2 plasmin inhibitor complex (PIC), plasminogen activator inhibitor 1 (PAI-1), t-PA-PAI-1 complex)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer 1 g of TXA intravenously in prehospital settings.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients over the age of 18 years.
2. Trauma patients who are transported by the doctor car or the helicopter to Nippon Medical School Hospital, Nippon Medical School Musashikosugi Hospital, Nippon Medical School Tama-Nagayama Hospital, or Nippon Medical School Chiba Hokuso Hospital.
3. Patients who are able to receive TXA in prehospital settings within 3 hours of the injury.
Key exclusion criteria
1. Patients with a history of hypersensitivity to TXA
2. Patients with diseases (liver disease, hematological diseases, infections, malignant neoplasms, pregnancy) that affect the coagulation fibrinolytic parameters.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Nakae |
Organization
Nippon Medical School
Division name
Department of Emergency and Critical Care Medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
nakae@nms.ac.jp
Public contact
Name of contact person
| 1st name | Ryuta |
| Middle name | |
| Last name | Nakae |
Organization
Nippon Medical School
Division name
Department of Emergency and Critical Care Medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
nakae@nms.ac.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Nippon Medical School Hospital
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
03-3822-2131
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
日本医科大学付属病院 高度救命救急センター、日本医科大学武蔵小杉病院 救命救急センター、日本医科大学多摩永山病院 救命救急センター、日本医科大学千葉北総病院 救命救急センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 21 | 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
34
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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047778
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