Visual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in Total Knee Arthroplasty
Primary Purpose
Total Knee Arthroplasty
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tranexamic Acid 100 MG/ML
Sponsored by

About this trial
This is an interventional treatment trial for Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:
Adults who have OA and need a total knee replacement.
Exclusion Criteria:
- Patients had abnormal blood coagulation.
- Patients were diagnosed as rheumatoid arthritis, traumatic osteoarthritis, ankylosing, spondylitis, hemophilic arthritis, peripheral vascular disease.
- Cold urticaria.
- Preoperative anticoagulation, patients had preoperative deep vein thrombosis (DVT).
- Preoperative history of anemia.
Sites / Locations
- The Second Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
Group A: Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.
Group B: No Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.
Outcomes
Primary Outcome Measures
Blood loss
Blood loss calculated by hemoglobin level
Secondary Outcome Measures
Full Information
NCT ID
NCT03934047
First Posted
April 24, 2019
Last Updated
April 30, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03934047
Brief Title
Visual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in Total Knee Arthroplasty
Official Title
Visual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2019 (Anticipated)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background and study aims Osteoarthritis (OA) is the most common type of arthritis, which most often affects the knee. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, which can cause stiffness, pain and a reduction in a person's range of movement. A knee joint replacement is a common procedure where the weight bearing surfaces of the knee joint are replaced with metal and plastic components to relieve the pain and disability brought on by OA. Tranexamic Acid(TXA) is a traditional method to reduce blood loss, pain score and complications. It is not known however, what is the best method of TXA for the patients with TKA. The aim of this study is to find out whetherVisual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in patients who have had knee replacement surgery.
Detailed Description
Who can participate? Adults who have OA and need a total knee replacement. What does the study involve? Participants are randomly allocated to one of three groups. For the interventions field, could you please provide a brief methodology for each of your treatment arms, and the total duration of treatment and follow-up? Group A: Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement. Group B: No Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.
The blood loss, VAS pain scores, length of their hospital stay, swelling and bleeding, and range of motion of the affected knee are assessed in the days following surgery.
What are the possible benefits and risks of participating? Participants who are allocated to receive treatment with Visual Field Infiltration of Tranexamic Acid may benefit from a reduction in blood loss, pain, swelling and blood loss after surgery, shortening their hospital stay.
There is a small risk of discomfort, frostbite or deep vein thrombosis (a blood clot in a major vein in the leg) when using Visual Field Infiltration of Tranexamic Acid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A: Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Group B: No Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 100 MG/ML
Intervention Description
Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.
Primary Outcome Measure Information:
Title
Blood loss
Description
Blood loss calculated by hemoglobin level
Time Frame
1 week after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults who have OA and need a total knee replacement.
Exclusion Criteria:
Patients had abnormal blood coagulation.
Patients were diagnosed as rheumatoid arthritis, traumatic osteoarthritis, ankylosing, spondylitis, hemophilic arthritis, peripheral vascular disease.
Cold urticaria.
Preoperative anticoagulation, patients had preoperative deep vein thrombosis (DVT).
Preoperative history of anemia.
Facility Information:
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang, M.D.
Phone
86-571-13656671144
Email
sunny01@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Visual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in Total Knee Arthroplasty
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