UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044127 |
|---|---|
| Receipt number | R000050390 |
| Scientific Title | Evaluation of the efficacy and safety of thromboprophylaxis regimens in patients after the Fontan procedure |
| Date of disclosure of the study information | 2021/05/07 |
| Last modified on | 2024/05/13 09:57:56 |
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Basic information
Public title
Evaluation of the efficacy and safety of thromboprophylaxis regimens in patients after the Fontan procedure
Acronym
Evaluation of the efficacy and safety of thromboprophylaxis regimens in patients after the Fontan procedure
Scientific Title
Evaluation of the efficacy and safety of thromboprophylaxis regimens in patients after the Fontan procedure
Scientific Title:Acronym
Evaluation of the efficacy and safety of thromboprophylaxis regimens in patients after the Fontan procedure
Region
| Japan |
Condition
Condition
Patients after the Fontan procedure
Classification by specialty
| Cardiology | Vascular surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of each antithrombotic therapy with warfarin and aspirin for 1 year after the Fontan procedure using the National Data Base (NDB)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of first thromboembolism for 1 year
Key secondary outcomes
Occurrence of bleeding events for 1 year
Base
Study type
Observational
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
Patients who underwent fontan procedure between June 2011 and September 2019 included in the data set from March 2011 to September 2020
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Kogo |
Organization
Showa University
Division name
Pharmacotherapy Department
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8220
mari-k@pharm.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohbayashi |
Organization
Showa University
Division name
Department of Pharmacotherapy, Department of Clinical Pharmacy,School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8221
Homepage URL
ohbayashi@pharm.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.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
| 2021 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37782971/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37782971/
Number of participants that the trial has enrolled
1903
Results
In total, 1,903 patients were included in the analysis. The median age at the time of the Fontan operation was 3 (1 to 22) years, and 1,067 patients (56%) were male. The incidence rates of TEs and bleeding events were 12% and 11%, respectively.
Results date posted
| 2024 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
We conducted a retrospective cohort study including 2,515 patients who underwent the Fontan operation between June 2011 and September 2019.
Participant flow
We conducted a retrospective cohort study including 2,515 patients who underwent the Fontan operation between June 2011 and September 2019.
Adverse events
N/A
Outcome measures
The end points were TEs and bleeding events within 1 year of the Fontan operation analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050390
