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Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Peri-articular tranexamic acid
Intravenous tranexamic acid
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Tranexamic acid, Peri-articular injection, Total knee arthroplasty, Blood loss, Osteoarthritis, Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients with osteoarthritis in need of a TKA

Exclusion Criteria:

  • inflammatory arthritis
  • post-traumatic arthritis
  • a history of or current venous thromboembolic disease
  • any underlying disease of haemostasis
  • cirrhosis
  • chronic renal failure
  • patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
  • know allergy to TXA
  • defective color vision
  • preoperative hemoglobin <10 g/dL
  • platelet count < 140,000 /uL3

Sites / Locations

  • Orthopaedic department, Thammasat university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peri-articular group

Intravenous group

Arm Description

Patients received 750 mg of peri-articular Tranexamic acid (Transamin®; OLIC Thailand Ltd, Bangkok, Thailand; 250 mg/5 mL, 15 cc total volume) injection into the soft tissue around medial capsule (5 ml), lateral capsule (5 ml) and around the quadriceps muscle (5 ml), 10 minutes prior to deflating the tourniquet and wound closure.

Patients received 750 mg of intravenous tranexamic acid(250 mg/5 ml, 15 cc total volume, keeping within the therapeutic range of 10-15 mg/kg/dose), 10 minutes prior to deflating the tourniquet and wound closure.

Outcomes

Primary Outcome Measures

The volume of postoperative blood loss in the drain
Changes from baseline hemoglobin concentrations
unit of blood transfusion

Secondary Outcome Measures

Knee diameter for swelling
number of patient with venous thromboembolism

Full Information

First Posted
July 5, 2016
Last Updated
July 11, 2016
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT02829346
Brief Title
Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty
Official Title
Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.
Detailed Description
Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Tranexamic acid, Peri-articular injection, Total knee arthroplasty, Blood loss, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peri-articular group
Arm Type
Experimental
Arm Description
Patients received 750 mg of peri-articular Tranexamic acid (Transamin®; OLIC Thailand Ltd, Bangkok, Thailand; 250 mg/5 mL, 15 cc total volume) injection into the soft tissue around medial capsule (5 ml), lateral capsule (5 ml) and around the quadriceps muscle (5 ml), 10 minutes prior to deflating the tourniquet and wound closure.
Arm Title
Intravenous group
Arm Type
Active Comparator
Arm Description
Patients received 750 mg of intravenous tranexamic acid(250 mg/5 ml, 15 cc total volume, keeping within the therapeutic range of 10-15 mg/kg/dose), 10 minutes prior to deflating the tourniquet and wound closure.
Intervention Type
Drug
Intervention Name(s)
Peri-articular tranexamic acid
Other Intervention Name(s)
Transamin
Intervention Description
750 mg of peri-articular TXA, prior to deflating the tourniquet and wound closure
Intervention Type
Drug
Intervention Name(s)
Intravenous tranexamic acid
Other Intervention Name(s)
Transamin
Intervention Description
750 mg of IV TXA, prior to deflating the tourniquet and wound closure
Primary Outcome Measure Information:
Title
The volume of postoperative blood loss in the drain
Time Frame
48 hours after the operation
Title
Changes from baseline hemoglobin concentrations
Time Frame
48 hours after the operation
Title
unit of blood transfusion
Time Frame
48 hours after the operation
Secondary Outcome Measure Information:
Title
Knee diameter for swelling
Time Frame
At 24 and 48 hours after the operation
Title
number of patient with venous thromboembolism
Time Frame
At 14 days after the operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients with osteoarthritis in need of a TKA Exclusion Criteria: inflammatory arthritis post-traumatic arthritis a history of or current venous thromboembolic disease any underlying disease of haemostasis cirrhosis chronic renal failure patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel) know allergy to TXA defective color vision preoperative hemoglobin <10 g/dL platelet count < 140,000 /uL3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piya Pinsornsak, MD
Organizational Affiliation
Faculty of Medicine, Thammasat university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic department, Thammasat university hospital
City
Klongluang
State/Province
Pathumthani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
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Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

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