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The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis,Knee

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Peri-articular TXA (15 mg/kg)
Intraarticular TXA 2 g (40 mL)
TXA combined with multimodal local anesthetic infiltration inject into peri-articular area
TXA 40 mL inject into intraaricular knee capsule
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, Intraarticular injection, Total knee arthroplasty, Blood loss

Eligibility Criteria

40 Years - 90 Years (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)
  • Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3
  • Allergy to TXA

Sites / Locations

  • Thammasat university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Peri-articular tranexamic acid injection

Intraarticular tranexamic acid injection

Control group

Arm Description

TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)

TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration

Don't receive any route of TXA

Outcomes

Primary Outcome Measures

Changes from baseline hemoglobin concentrations
Unit of blood transfusion

Secondary Outcome Measures

Tranexamic acid level in blood
Knee diameter for swelling
Local soft tissue complications
Skin necrosis
Number of patient with venous thromboembolism
Visual Analogue Scales
(VAS, 0 = no pain, 10 = the worst imaginable pain)
Knee flexion angle

Full Information

First Posted
November 20, 2016
Last Updated
April 23, 2019
Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT03074994
Brief Title
The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty
Official Title
The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.
Detailed Description
Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.

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, Intraarticular injection, Total knee arthroplasty, Blood loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peri-articular tranexamic acid injection
Arm Type
Experimental
Arm Description
TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
Arm Title
Intraarticular tranexamic acid injection
Arm Type
Experimental
Arm Description
TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Don't receive any route of TXA
Intervention Type
Drug
Intervention Name(s)
Peri-articular TXA (15 mg/kg)
Intervention Description
combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL
Intervention Type
Drug
Intervention Name(s)
Intraarticular TXA 2 g (40 mL)
Intervention Description
inject separate from multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 75 mL)
Intervention Type
Procedure
Intervention Name(s)
TXA combined with multimodal local anesthetic infiltration inject into peri-articular area
Intervention Description
(Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation
Intervention Type
Procedure
Intervention Name(s)
TXA 40 mL inject into intraaricular knee capsule
Intervention Description
after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation
Primary Outcome Measure Information:
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
Tranexamic acid level in blood
Time Frame
2 and 24 hours after the operation
Title
Knee diameter for swelling
Time Frame
24 and 48 hours after the operation
Title
Local soft tissue complications
Time Frame
14 days after the operation
Title
Skin necrosis
Time Frame
24 and 48 hours after the operation
Title
Number of patient with venous thromboembolism
Time Frame
14 days after the operation
Title
Visual Analogue Scales
Description
(VAS, 0 = no pain, 10 = the worst imaginable pain)
Time Frame
24 and 48 hours after the operation
Title
Knee flexion angle
Time Frame
24 and 48 hours after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
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) Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3 Allergy to TXA
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piya Pinsornsak, MD
Email
pinpiya2003@yahoo.com
Facility Information:
Facility Name
Thammasat university hospital
City
Pathumthani
State/Province
Klongluang
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piya Pinsornsak, MD
Phone
02-926-9705
Email
pinpiya2003@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
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The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty

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