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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017980
Receipt No. 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

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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
Email 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
Email rychr.0758@gmail.com

Sponsor
Institute London School of Hygiene & Tropical Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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