UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of early tranexamic acid administration in traumatic brain injury patients: a systematic review and meta-analysis
Acronym	Efficacy and safety of early tranexamic acid administration in traumatic brain injury patients: a systematic review and meta-analysis
Scientific Title	Efficacy and safety of early tranexamic acid administration in traumatic brain injury patients: a systematic review and meta-analysis
Scientific Title:Acronym	Efficacy and safety of early tranexamic acid administration in traumatic brain injury patients: a systematic review and meta-analysis
Region	Japan

Condition
Condition	Traumatic brain injury
Classification by specialty	Neurosurgery Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The exacerbation of intracranial bleeding is critical in traumatic brain injury (TBI) patients. Tranexamic acid (TXA) has been used to improve outcomes in TBI patient. However, the effectiveness of early TXA treatment remains unclear. This study aimed to assess the effect of early administration of TXA on clinical outcomes in patients with TBI by systematically reviewing the literature and synthesizing evidence of randomized controlled trials (RCTs).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Mortality
Key secondary outcomes	good neurological outcome rates, enlargement of bleeding, incidence of ischemia, and hemorrhagic intracranial complications.

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	MEDLINE, the Cochrane Central Register of Controlled Trials, and Igaku Chuo Zasshi (ICHUSHI) Web were searched. Selection criteria included randomized controlled trials with clinical outcomes of adult TBI patients administered TXA or placebo in the early phase after admission.
Key exclusion criteria	MEDLINE, the Cochrane Central Register of Controlled Trials, and Igaku Chuo Zasshi (ICHUSHI) Web were searched. Selection criteria included randomized controlled trials with clinical outcomes of adult TBI patients administered TXA or placebo in the early phase after admission.
Target sample size

Research contact person
Name of lead principal investigator	1st name Shoji Middle name Last name Yokobori
Organization	Nippon Medical School
Division name	Department of Emergency and Critical Care Medicine
Zip code	1138603
Address	1-1-5 Sendagi, Bunkyo-Ku, Tokyom Japan
TEL	81338222131
Email	shoji@nms.ac.jp

Public contact
Name of contact person	1st name Shoji Middle name Last name yokobori
Organization	Nippon Medical School
Division name	Department of Emergency and Critical Care Medicine
Zip code	1138603
Address	1-1-5 Sendagi, Bunkyo-Ku, Tokyom Japan
TEL	81338222131
Homepage URL
Email	shoji@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	Nippon Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School
Address	1-1-5 sendagi
Tel	81338222131
Email	shoji@nms.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	2020 Year 05 Month 13 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	2020 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date	2020 Year 05 Month 13 Day
Last follow-up date	2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Results:A total of 640 records were screened. Seven studies were included for quantitative analysis. Of 10,044 patients from seven of the included studies, 5,076 were randomly assigned to the TXA treatment group and 4,968 were assigned to placebo. In the TXA treatment group, 914 patients (18.0 %) died, while 961 patients (19.3%) died in the placebo group No significant differences between the groups in other important outcomes were also observed. Conclusions: Early TXA treatment demonstrated a tendency to reduce head trauma-related deaths in the TBI population, with no significant incidence of thromboembolic events. TXA treatment may therefore be suggested in the initial TBI care.

Management information
Registered date	2020 Year 05 Month 13 Day
Last modified on	2020 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046090