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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026137
Receipt No. R000030035
Scientific Title Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total knee arthroplasty: randomized controlled trial
Date of disclosure of the study information 2017/02/14
Last modified on 2019/10/23

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Basic information
Public title Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total knee arthroplasty: randomized controlled trial
Acronym Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral TKA: randomized controlled trial
Scientific Title Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total knee arthroplasty: randomized controlled trial
Scientific Title:Acronym Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral TKA: randomized controlled trial
Region
Japan

Condition
Condition Osteoarthritis of the knee
Rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether combined intravenous and intra-articular administration of tranexamic acid reduced perioperative blood loss compared with intravenous-only administration of tranexamic acid for the patients undergoing simultaneous bilateral total knee arthroplasty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 3
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 NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first knee. After closure of the capsule and retinaculum, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each knee. Six hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.
Interventions/Control_2 The intravenous tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first knee. After closure of the capsule and retinaculum, 10 mL of normal saline was administered intra-articularly for each knee. Six hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.
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 simultaneous bilateral total knee arthroplasty
Key exclusion criteria Known allergic reaction to tranexamic acid
Patients with preoperative hemoglobin level < 11.0 g/dL
Refusal of blood products
Enrollment in another interventional clinical trial within 6 months prior to surgery
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Hokusuikai Kinen Hospital
Division name Orthopaedic Surgery
Zip code
Address 3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL 0293033003
Email s8058@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Hokusuikai Kinen Hospital
Division name Orthopaedic Surgery
Zip code
Address 3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL 0293033003
Homepage URL
Email s8058@nms.ac.jp

Sponsor
Institute Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization Hokusuikai Kinen 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
Address
Tel
Email

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
2017 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2890-8
Number of participants that the trial has enrolled 77
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 Completed
Date of protocol fixation
2017 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 14 Day
Last modified on
2019 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030035

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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