UMIN-CTR Clinical Trial

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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