UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054871 |
|---|---|
| Receipt number | R000062694 |
| Scientific Title | Dose comparison of flowable gelatin hemostatic matrix for bleeding loss in primary arthroplasty |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/03 18:29:34 |
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Basic information
Public title
Change in Bleeding Volume in Arthroplasty by Type of Hemostatic Agent
Acronym
Change in Bleeding Volume in Arthroplasty by Type of Hemostatic Agent
Scientific Title
Dose comparison of flowable gelatin hemostatic matrix for bleeding loss in primary arthroplasty
Scientific Title:Acronym
Dose comparison of flowable gelatin hemostatic matrix for bleeding loss in primary arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis for effectiveness of hemostatic agent during Arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative changes in blood loss during arthroplasty
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of "hemostatic agents," which are believed to stop bleeding from bone marrow and soft tissue in arthroplasty
Interventions/Control_2
No use of "hemostatic agents," which are believed to stop bleeding from bone marrow and soft tissue in arthroplasty
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing Arthroplasty as usual
Key exclusion criteria
patients who rejected to participate this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Matsuda |
Organization
University of Oita, Oita, Japan
Division name
Dept. of Orthop. Surg.
Zip code
879-5593
Address
1-1 Idaigaoka Hasama Yuhu City, Oita
TEL
0975865872
s-matsuda@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Matsuda |
Organization
University of Oita, Oita, Japan
Division name
Dept. of Orthop. Surg.
Zip code
879-5593
Address
1-1 Idaigaoka Hasama Yuhu City, Oita
TEL
08039678476
Homepage URL
s-matsuda@oita-u.ac.jp
Sponsor or person
Institute
University of Oita, Oita, Japan
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Dept. of Orthop. Surg., University of Oita, Oita, Japan
Address
1-1 Idaigaoka Hasama Yuhu City, Oita
Tel
0975865872
s-matsuda@oita-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
| 2024 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | 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
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062694
