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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039611
Receipt No. R000044795
Scientific Title Safety of tranexamic acid in thrombotic adverse events and seizure in hemorrhagic patients: a systematic review and meta-analysis
Date of disclosure of the study information 2020/02/26
Last modified on 2020/09/06

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Basic information
Public title Safety of tranexamic acid in thrombotic adverse events and seizure in hemorrhagic patients: a systematic review and meta-analysis
Acronym Safety of tranexamic acid in thrombotic adverse events and seizure in hemorrhagic patients: a systematic review and meta-analysis
Scientific Title Safety of tranexamic acid in thrombotic adverse events and seizure in hemorrhagic patients: a systematic review and meta-analysis
Scientific Title:Acronym Safety of tranexamic acid in thrombotic adverse events and seizure in hemorrhagic patients: a systematic review and meta-analysis
Region
Japan

Condition
Condition Patients with bleeding in any underlying disease
Classification by specialty
Surgery in general Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the incidence of thrombotic adverse events and seizure and how the effect of TXA varies by dose and underlying disease
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The occurrence of any thrombotic adverse events, including acute coronary syndrome (ACS), stroke/transient ischemic attack (TIA), and venous thromboembolism (VTE), and seizure.
Key secondary outcomes The occurrence of ACS, stroke/TIA, and VTE will be assessed separately.

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 We will include patients administered TXA for any underlying disease such as trauma, surgery, post-partum hemorrhage, spontaneous intracranial hemorrhage, and gastrointestinal hemorrhage.
Key exclusion criteria Studies done with animals will be excluded from this review.
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name SHUHEI
Middle name
Last name MURAO
Organization Osaka General Medical Center
Division name Division of Trauma and Surgical Critical Care
Zip code 558-8558
Address Bandai-Higashi, Sumiyoshi, Osaka
TEL 81-6-6692-1201
Email shmu20268271@gmail.com

Public contact
Name of contact person
1st name Kazuma
Middle name
Last name Yamakawa
Organization Osaka General Medical Center
Division name Division of Trauma and Surgical Critical Care
Zip code 558-8558
Address Bandai-Higashi, Sumiyoshi, Osaka
TEL +81-6-6692-1201
Homepage URL
Email k.yamakawa0911@gmail.com

Sponsor
Institute Osaka General Medical Center, Division of Trauma and Surgical Critical Care
Institute
Department

Funding Source
Organization ZENKYOREN (National Mutual Insurance Federation of Agricultural Cooperatives)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka General Medical Center
Address Bandai-Higashi, Sumiyoshi, Osaka, Japan
Tel +81-6-6692-1201
Email k.yamakawa0911@gmail.com

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 02 Month 26 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 No longer recruiting
Date of protocol fixation
2019 Year 11 Month 27 Day
Date of IRB
2020 Year 01 Month 30 Day
Anticipated trial start date
2020 Year 01 Month 30 Day
Last follow-up date
2020 Year 02 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Systematic review and meta-analysis

Management information
Registered date
2020 Year 02 Month 26 Day
Last modified on
2020 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044795

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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