UMIN-CTR Clinical Trial

Public title

The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty

Acronym

The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty

Scientific Title

The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty

Scientific Title:Acronym

The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty

Region

Japan

Condition

Osteoarthritis of the knee
Rheumatoid arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to assess the postoperative blood loss and clinical course in the patients undegoing TKA using local injection of TXA by comparing the obtained results with those of drain clamping.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The volume of estimated total blood loss in postoperative day3.

Key secondary outcomes

drainage blood volume
Postoperative around the knee circumference
postoperative serum D-dimer level
postoperative compliations

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

In the TXA local injection group, 25ml saline containing of 10 mg/kg TXA was injected into the area around medial,lateral,and posterior capsule, the quadriceps muscle tendon, and the infrapatellar fat pad just prior to incision closure.

Interventions/Control_2

In the drane clamping group,30ml saline containing of 10 mg/kg TXA was injected
was injected immediately after wound closure through a 3.2-mm diameter drain.This tube was clamped and closed completely
for 2 hours, then the clamp was released.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

99

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients undergoing TKA

Key exclusion criteria

Patient with a history of thrombosis
Patient with a severe renal disfunction
Patients who need to restart internal anticoagulant as soon as possible postoperatively
Patients deemed inappropriate as research subjects

Target sample size

144

Name of lead principal investigator

1st name	Ryosuke
Middle name
Last name	Hishimura

Organization

Department of Orthopaedic Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University

Division name

Orthopaedic Surgery

Zip code

060-8638

Address

North 15 West 7, Kita-Ku, Sapporo 060-8638, Japan

TEL

0117065936

Email

ryosukehishimura@yahoo.co.jp

Name of contact person

1st name	Yasumitsu
Middle name
Last name	Ohkoshi

Organization

Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan

Division name

Orthopaedic Surgery

Zip code

041-0802

Address

2-115 Ishikawa-cho, Hakodate, 041-0802, Japan

TEL

0138-34-5700

Homepage URL

Email

youhoc1957mykd@gmail.com

Institute

Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan

Institute

Department

Personal name

Organization

Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan

Address

2-115 Ishikawa-cho, Hakodate, 041-0802, Japan

Tel

0138-34-5700

Email

youhoc1957mykd@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

函館整形外科クリニック（北海道）、北海道大学病院（北海道）

Date of disclosure of the study information

2019

Year

03

Month

10

Day

URL releasing protocol

http://hakodate-seikei.com

Publication of results

Unpublished

URL related to results and publications

http://hakodate-seikei.com

Number of participants that the trial has enrolled

120

Results

The calculated total blood loss (CTBL) in groups L and D was nearly equal and did not show the non-inferiority of group L to group D (883 vs. 841 ml, P .564). Drained blood loss was significantly higher in group L than in group D (395 vs 276 ml, P .0001). There was no significant difference in hidden blood loss between the groups (488 vs 565 ml, P .131). The other laboratory findings and physical measurements were identical between the groups.

Results date posted

2022

Year

09

Month

26

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

A total of 120 consecutive patients who were scheduled for primary unilateral TKA in Hakodate Orthopedic Clinic. The recruitment start date for the study was 18 September 2018, and the recruitment end date was 31 July 2019. The study was conducted between 1 October 2018 and 30 August 2019. This was a randomized, prospective study which was registered with UMIN Clinical Trials Registry.

Participant flow

Exclusion criteria included the patient underwent extensive synovectomy during surgery due to severe synovitis, use of allogenic blood transfusion postoperatively, and a patient whose drain appeared to be clogged, that is, postoperative volume of drained blood less than 100 ml. Also, it was decided to stop the study if intraoperative surgical and medical complications, such as intraoperative fracture, neurovascular injury, or myocardial infarction occurred.

Adverse events

None

Outcome measures

The calculated total blood loss (CTBL) was taken as the primary outcome measure. The CTBL was calculated using a specific formula (27, 28) as the difference between the preoperative and postoperative day (POD) 3 hemoglobin (Hb) level. Secondary outcome measures were as follows. The evaluated blood tests were the volume of drained blood loss (DBL) at postoperative 24 h, hidden blood loss (HBL) on POD 3, and the D-dimer level on POD 7. To evaluate postoperative knee pain, patients were asked to describe their usual knee pain as a numerical rating scale (NRS) on PODs 5 and 10. The NRS is commonly used for the assessment of pain intensity (29, 30) and it is an 11-point scale comprising a number from 0 through 10; 0 indicates no pain, and 10 indicates the worst imaginable pain. As physical measurements, the range of motion (ROM) on POD 14 and the circumference of the leg at the superior patellar border (suprapatellar girth), 10 cm above the border (thigh girth), and the maximum circumference of the calf (calf girth) on PODs 5 and 10 were measured. Adverse events occurring within POD 14 were also examined. HBL was calculated by subtracting DBL from CTBL, considering that there was almost no bleeding during surgery. The postoperative circumference was evaluated as a percentage based on each preoperative value.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

03

Month

07

Day

Date of IRB

2018

Year

07

Month

23

Day

Anticipated trial start date

2018

Year

10

Month

01

Day

Last follow-up date

2019

Year

08

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

03

Month

10

Day

Last modified on

2022

Year

09

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041178