UMIN-CTR Clinical Trial

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