UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028871
Receipt number R000033037
Scientific Title Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Date of disclosure of the study information 2017/08/29
Last modified on 2019/09/03 00:23:32

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Basic information

Public title

Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.

Acronym

Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.

Scientific Title

Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.

Scientific Title:Acronym

Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.

Region

Japan


Condition

Condition

osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome is total blood loss (postoperative day 1).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

After the skin incision was closed, tranexamic acid is infiltrated into the joint.

Interventions/Control_2


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

Ptients undergoing primary arthroplasty.

Key exclusion criteria

Patients with allergy to tranexamic acid, preoperative renal dysfunction, deranged coagulation profile and history of thromboembolic disease.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Hasegawa

Organization

Mie University Graduate School of Medicine

Division name

Orthopaedic Surgery

Zip code

514-8507

Address

2-174 Edobashi Tsu Mie

TEL

0592321111

Email

seikei@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name Yohei
Middle name
Last name Naito

Organization

Mie University Graduate School of Medicine

Division name

Orthopaedic Surgery

Zip code

514-8507

Address

2-174 Edobashi Tsu Mie

TEL

0592321111

Homepage URL


Email

seikei@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding.

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

Mie University Hospital

Address

2-174 Edobashi Tsu Mie

Tel

0592321111

Email

kk-sien@mo.medic.mie-u.ac.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

2017 Year 08 Month 29 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

Open public recruiting

Date of protocol fixation

2016 Year 12 Month 14 Day

Date of IRB

2016 Year 11 Month 24 Day

Anticipated trial start date

2016 Year 12 Month 15 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 28 Day

Last modified on

2019 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033037


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name