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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040389
Receipt No. R000046090
Scientific Title Efficacy and safety of early tranexamic acid administration in traumatic brain injury patients: a systematic review and meta-analysis
Date of disclosure of the study information 2020/05/13
Last modified on 2020/05/13

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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
Interventions/Control_8
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

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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