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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047607
Receipt No. 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 2022/04/27

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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
Email 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
Email kenpiecekenpiece@yahoo.co.jp

Sponsor
Institute Shiraniwa Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 02 Month 02 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 04 Month 27 Day
Last modified on
2022 Year 04 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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