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

NCT03074994 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-04-24

No results posted yet for this study

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.

Conditions

  • Osteoarthritis,Knee

Interventions

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

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 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

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

Sponsors & Collaborators

  • Boontanapibul, Krit, M.D.

    collaborator INDIV

  • Thammasat University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074994 on ClinicalTrials.gov