UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036146 |
|---|---|
| Receipt number | R000041178 |
| Scientific Title | The hemostatic effect of local injection of tranexamic acid into peri-articular tissue in total knee arthroplasty |
| Date of disclosure of the study information | 2019/03/10 |
| Last modified on | 2022/09/26 15:29:54 |
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Basic information
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
Condition
Osteoarthritis of the knee
Rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
ryosukehishimura@yahoo.co.jp
Public contact
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
youhoc1957mykd@gmail.com
Sponsor or person
Institute
Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan
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
Department of Orthopedic Surgery, Hakodate Orthopedic Clinic, Japan
Address
2-115 Ishikawa-cho, Hakodate, 041-0802, Japan
Tel
0138-34-5700
youhoc1957mykd@gmail.com
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
函館整形外科クリニック（北海道）、北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
http://hakodate-seikei.com
Publication of results
Unpublished
Result
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
Progress
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
Other related information
Management 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
