UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055094 |
|---|---|
| Receipt number | R000061562 |
| Scientific Title | Evaluation of a protocol-based management of anticoagulants in hemodialysis during invasive procedure |
| Date of disclosure of the study information | 2024/07/28 |
| Last modified on | 2025/07/30 12:27:27 |
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Basic information
Public title
Efficacy of the protocol for the selection of anticoagulants in hemodialysis
Acronym
The protocol of anticoagulants in hemodialysis
Scientific Title
Evaluation of a protocol-based management of anticoagulants in hemodialysis during invasive procedure
Scientific Title:Acronym
Protocol-Based Control of anticoagulants in hemodialysis
Region
| Japan |
Condition
Condition
Patients in hemodialysis during invasive procedure
Classification by specialty
| Gastroenterology | Nephrology | Surgery in general |
| Operative medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
On the change of the anticoagulant in hemodialysis during invasive procedure, the situation in which the protocol was carried out is investigated, and the effectiveness is examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Compliance with the protocol for changing anticoagulants in hemodialysis
Key secondary outcomes
Complications in patients in hemodialysis during invasive procedure
Types and dosages of anticoagulants used in hemodialysis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients admitted to our hospital for invasive procedure.
Key exclusion criteria
Cases in which disapproval of this study was offered based on the information
Cases in which invasive procedures were not performed
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakai |
Organization
Japanese Red Cross Fukuoka Hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, Japan
TEL
092-521-1211
k-nakai@fukuoka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakai |
Organization
Japanese Red Cross Fukuoka Hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, Japan
TEL
092-521-1211
Homepage URL
k-nakai@fukuoka-med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Fukuoka Hospital
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
Japanese Red Cross Fukuoka Hospital
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, Japan
Tel
092-521-1211
fukuoka-kenkyu@fukuoka-med.jrc.or.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
| 2024 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jsdt/58/4/58_192/_article/-char/ja
Number of participants that the trial has enrolled
229
Results
The study included 229 patients who received surgery in the Departments of Surgery, Ophthalmology, and Urology and also those who underwent endoscopic mucosal resection in the Department of Gastroenterology. Perioperative management of patients who undergo hemodialysis requires interdepartmental and interprofessional collaboration, and protocols for anticoagulation modification in patients who undergo hemodialysis are important tools to facilitate team medicine.
Results date posted
| 2025 | Year | 07 | Month | 30 | Day |
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
Main results already published
Date of protocol fixation
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
How the anticoagulant used for hemodialysis is changed during invasive procedure, the compliance situation of the protocol is investigated, and the effectiveness is examined. In addition, safety and problem of the protocol-based control of anticoagulants in hemodialysis, type and usage of the anticoagulants used in the hemodialysis are clarified.
Management information
Registered date
| 2024 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061562
