Clinical trial NCT02829346: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Tranexamic acid
Peri-articular injection
Total knee arthroplasty
Blood loss
Osteoarthritis, Knee
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The volume of postoperative blood loss in the drain
timeFrame: 48 hours after the operation
measure: Changes from baseline hemoglobin concentrations
timeFrame: 48 hours after the operation
measure: unit of blood transfusion
timeFrame: 48 hours after the operation
Secondary outcomes:
measure: Knee diameter for swelling
timeFrame: At 24 and 48 hours after the operation
measure: number of patient with venous thromboembolism
timeFrame: At 14 days after the operation
Other outcomes:
Locations:
city: Klongluang
country: Thailand
facility: Orthopaedic department, Thammasat university hospital
state: Pathumthani
Study officials:
affiliation: Faculty of Medicine, Thammasat university
name: Piya Pinsornsak, MD
role: PRINCIPAL_INVESTIGATOR
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