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

April 23, 2019 updated by: piya pinsornsak, Thammasat University

The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Klongluang
      • Pathumthani, Klongluang, Thailand, 12120
        • Recruiting
        • Thammasat University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Peri-articular tranexamic acid injection
TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
Drug: Peri-articular TXA (15 mg/kg)
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
Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area
(Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation
EXPERIMENTAL: Intraarticular tranexamic acid injection
TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration
Drug: Intraarticular TXA 2 g (40 mL)
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)
Procedure: TXA 40 mL inject into intraaricular knee capsule
after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation
NO_INTERVENTION: Control group
Don't receive any route of TXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline hemoglobin concentrations
Time Frame: 48 hours after the operation
48 hours after the operation
Unit of blood transfusion
Time Frame: 48 hours after the operation
48 hours after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tranexamic acid level in blood
Time Frame: 2 and 24 hours after the operation
2 and 24 hours after the operation
Knee diameter for swelling
Time Frame: 24 and 48 hours after the operation
24 and 48 hours after the operation
Local soft tissue complications
Time Frame: 14 days after the operation
14 days after the operation
Skin necrosis
Time Frame: 24 and 48 hours after the operation
24 and 48 hours after the operation
Number of patient with venous thromboembolism
Time Frame: 14 days after the operation
14 days after the operation
Visual Analogue Scales
Time Frame: 24 and 48 hours after the operation
(VAS, 0 = no pain, 10 = the worst imaginable pain)
24 and 48 hours after the operation
Knee flexion angle
Time Frame: 24 and 48 hours after the operation
24 and 48 hours after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Collaborators

Boontanapibul, Krit, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

March 8, 2017

First Posted (ACTUAL)

March 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-OT-6-063/59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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