Visual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in Total Knee Arthroplasty

NCT ID: NCT03934047

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-26
• Study Completion Date: 2020-06-01

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

Group A: Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.

Group Type: EXPERIMENTAL

Tranexamic Acid 100 MG/ML

Intervention Type: DRUG

Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.

Group B

Group B: No Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tranexamic Acid 100 MG/ML

Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Adults who have OA and need a total knee replacement.

Exclusion Criteria

1. Patients had abnormal blood coagulation.

2. Patients were diagnosed as rheumatoid arthritis, traumatic osteoarthritis, ankylosing, spondylitis, hemophilic arthritis, peripheral vascular disease.

3. Cold urticaria.

4. Preoperative anticoagulation, patients had preoperative deep vein thrombosis (DVT).

5. Preoperative history of anemia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Facility Contacts

Wei Wang, M.D.

Role: primary

sunny01@zju.edu.cn

86-571-13656671144

Other Identifiers

2018-126

Identifier Type: -

Identifier Source: org_study_id