UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039611 |
|---|---|
| Receipt number | 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 17:14:57 |
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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
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
k.yamakawa0911@gmail.com
Sponsor or person
Institute
Osaka General Medical Center, Division of Trauma and Surgical Critical Care
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044795
