UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035584 |
|---|---|
| Receipt number | 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 | 2023/07/24 15:58:59 |
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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
30
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Inoue |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Departments of Neurosurgery
Zip code
8608556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto City, Kumamoto, Japan
TEL
096-373-5219
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
iwasaki-yuri@hitoyoshi.jcho.go.jp
Sponsor or person
Institute
Departments of Neurosurgery, Hitoyoshi Medical Center
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
now analyzing
Number of participants that the trial has enrolled
35
Results
Ninety patients comprised the non-administration group. Univariate analysis showed that the mRS score on day 90 was better in the administration group. The mRS scores on the day of death or discharge suggested a favorable effect of tranexamic acid treatment. Multivariable logistic regression analysis showed that tranexamic acid treatment resulted in good mRS scores at day 90.
Results date posted
| 2021 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
age, sex, ICH location, ICH size, intraventricular hemorrhage (IVH) measurement (Modified Graeb Score), pre-onset mRS score, GCS score at admission, and antithrombotic drug history
Participant flow
The prognosis was investigated until 90 days later.
Adverse events
none
Outcome measures
The primary outcome was mRS score on day 90. The secondary outcomes included hematoma expansion on day 2, GCS score on day 7, and mRS score on the day of death or hospital discharge (whichever came first).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040551
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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