UMIN-CTR Clinical Trial

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