UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017980 |
|---|---|
| Receipt number | R000020829 |
| Scientific Title | Tranexamic acid for the treatment of significant traumatic brain injury: an international randomised, double blind placebo controlled trial |
| Date of disclosure of the study information | 2015/06/20 |
| Last modified on | 2019/06/24 09:25:15 |
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Basic information
Public title
Tranexamic acid for the treatment of significant traumatic brain injury:
an international randomised, double blind placebo controlled trial
Acronym
Clinical randomisation of an antifibrinolytic in significant head injury
(CRASH 3)
Scientific Title
Tranexamic acid for the treatment of significant traumatic brain injury:
an international randomised, double blind placebo controlled trial
Scientific Title:Acronym
Clinical randomisation of an antifibrinolytic in significant head injury
(CRASH 3)
Region
| Japan | Asia(except Japan) | North America |
| South America | Europe | Africa |
Condition
Condition
Traumatic Brain Injury
Classification by specialty
| Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The CRASH 3 trial will provide reliable evidence about the effect of tranexamic acid on mortality and disability in patients with TBI. The effect of TXA on the risk of vascular occlusive events and seizures will also be assessed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is death in hospital within 28 days of injury (cause-specific
mortality will also be recorded)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tranexamic acid
As primary injection, 1g of Tranexamic acid is solved in 100ml NaCl0.9% and injected with 10 minutes. As maintenance dose, 1g of Tranexamic acid is infused in 500ml isotonic solution for 8 hrs.
Interventions/Control_2
Placebo(sodium chloride 0.9%)
the procedure is the same as trial drug
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)adult with traumatic brain injury
2)within 8 hours of injury
3)any intracranial bleeding on CT scan or
GCS_<12 if no scan available
Key exclusion criteria
1)significant extra cranial bleeding (needing immediate blood transfusion)
2) antifibrinolytic agents in a patient
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Otomo |
Organization
Medical Hospital,Tokyo Medical and Dental University
Division name
Trauma and Acute Critical Care Medical Center
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-3813-6111
otomo.accm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Egashira |
Organization
Medical Hospital,Tokyo Medical and Dental University
Division name
Trauma and Acute Critical Care Medical Center
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-3813-6111
Homepage URL
rychr.0758@gmail.com
Sponsor or person
Institute
London School of Hygiene & Tropical Medicine
Institute
Department
Personal name
Funding Source
Organization
JP Moulton Charitable Trust
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board TMDU Medical Hospital
Address
1-5-45, Yushima, Bunkyo-ward, Tokyo, Japan
Tel
03-5803-4575
mkan-rinsho.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01402882
Org. issuing International ID_1
Clinical Trials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 20 | 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
28
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
| 2015 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020829
| 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 |
