UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047607 |
|---|---|
| Receipt number | R000054288 |
| Scientific Title | Randomized Control Trial for suppression of perioperative bleeding byetween tranexamic acid and surge cell. |
| Date of disclosure of the study information | 2022/05/07 |
| Last modified on | 2023/03/28 10:53:24 |
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Basic information
Public title
Randomized Control Trial for suppression of perioperative bleeding byetween tranexamic acid and surge cell.
Acronym
Randomized Control Trial for suppression of perioperative bleeding byetween tranexamic acid and surge cell.
Scientific Title
Randomized Control Trial for suppression of perioperative bleeding byetween tranexamic acid and surge cell.
Scientific Title:Acronym
Randomized Control Trial for suppression of perioperative bleeding byetween tranexamic acid and surge cell.
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tranexamic acid is popular as a method of suppression of perioperative bleeding, but surge-cells are used in the surgical field. Randomized comparative study to find out which is more useful in the field of orthopedic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated Blood loss
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Control : Tranexamic Acid 1-2g
Interventions/Control_2
Intervention : Surgi-cell less than 3g
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis of the Knee or Hip
Key exclusion criteria
Other than osteoarthritis, History of spine, hip, knee surgery, bilateral simultaneous THA or TKA, contralateral THA within 1 year after surgery / spine surgery / lower limb surgery / reoperation, stroke / neuromuscular disease paralysis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Orthopaedic Surgery
Zip code
6300136
Address
6-10-1 Shiraniwadai Ikoma-city Nara, Japan
TEL
0743-70-0022
kenpiecekenpiece@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Orthopaedic Surgery
Zip code
6300136
Address
6-10-1 Shiraniwadai Ikoma-city Nara, Japan
TEL
0743-70-0022
Homepage URL
kenpiecekenpiece@yahoo.co.jp
Sponsor or person
Institute
Shiraniwa Hospital
Institute
Department
Personal name
Funding Source
Organization
Shiraniwa Hospital
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
Shiraniwa Hospital
Address
6-10-1 Shiraniwadai Ikoma-city Nara, Japan
Tel
0743-70-0022
kenpiecekenpiece@yahoo.co.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
| 2022 | Year | 05 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054288
