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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035584
Receipt No. R000040551
Scientific Title Continuous Administration of Tranexamic acid for acute intra Cerebral Hemorrhage: a hospital-based trial
Date of disclosure of the study information 2019/01/23
Last modified on 2019/07/23

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Basic information
Public title Continuous Administration of Tranexamic acid for acute intra Cerebral Hemorrhage: a hospital-based trial
Acronym
CATCH trial
Scientific Title Continuous Administration of Tranexamic acid for acute intra Cerebral Hemorrhage: a hospital-based trial
Scientific Title:Acronym
CATCH trial
Region
Japan

Condition
Condition Intra cerebral hemorrhage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We search an effect of 14 days continuous administration of tranexamic acid for nonsurgical acute intra cerebral hemorrhage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glasgow Coma Scale at 1 week and at discharge
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We assigned the patients to one group given 750 mg/day of tranexamic acid for 14 days.
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 the patients who undergo nonsurgical treatment of spontaneous intracerebral hemorrhage
Key exclusion criteria GCS <9; treatment window >8h; intracerebral hemorrhage secondary to anticoagulation, thrombolysis, trauma, or a known underlying structural abnormality; patients for whom tranexamic acid was thought to be contraindicaterd; prestroke mRS >4; patients who receive surgical treatment; multiple intracerebral hemorrhage
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Inoue
Organization Tokuda Neurosurgical Hospital
Division name Departments of Neurosurgery
Zip code 8930011
Address 1-11248-1, Utsuma, Kanonya, Kagoshima, Japan
TEL 0994-44-1119
Email hiro2866@gmail.com

Public contact
Name of contact person
1st name Yuri
Middle name
Last name Iwasaki
Organization Hitoyoshi Medical Center
Division name Clinical research center
Zip code 8688555
Address 35 Roujin-cho Hitoyoshi, Kumamoto, Japan
TEL 0966-22-2191
Homepage URL
Email iwasaki-yuri@hitoyoshi.jcho.go.jp

Sponsor
Institute Departments of Neurosurgery, Hitoyoshi Medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hitoyoshi Medical Center
Address 35 Roujin-cho Hitoyoshi, Kumamoto, Japan
Tel 0966-22-2191
Email iwasaki-yuri@hitoyoshi.jcho.go.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
2019 Year 01 Month 23 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 05 Day
Date of IRB
2018 Year 08 Month 08 Day
Anticipated trial start date
2018 Year 08 Month 08 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 18 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040551

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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