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

NCT03934047 | Unknown DMC

• 1 other identifier: 2018-126
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Blood loss calculated by hemoglobin level

  1 week after operation

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Tranexamic Acid 100 MG/ML

Group B

NO INTERVENTION

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

Interventions

Tranexamic Acid 100 MG/ML DRUG

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

Group A

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who have OA and need a total knee replacement.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 1, 2019
• Study Start: April 26, 2019
• Primary Completion: December 30, 2019
• Study Completion: June 1, 2020
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

CN (1)