Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

NCT02829346 | Completed Phase 2 DMC

• 1 other identifier: MTU-EC-OT-0-096/54
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Tranexamic acid; Peri-articular injection; Total knee arthroplasty; Blood loss; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• The volume of postoperative blood loss in the drain

  48 hours after the operation

• Changes from baseline hemoglobin concentrations

  48 hours after the operation

• unit of blood transfusion

  48 hours after the operation

Secondary Outcomes (2)

• Knee diameter for swelling

  At 24 and 48 hours after the operation

• number of patient with venous thromboembolism

  At 14 days after the operation

Study Arms (2)

Peri-articular group

EXPERIMENTAL

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.

Drug: Peri-articular tranexamic acid

Intravenous group

ACTIVE COMPARATOR

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.

Drug: Intravenous tranexamic acid

Interventions

Peri-articular tranexamic acid DRUG

750 mg of peri-articular TXA, prior to deflating the tourniquet and wound closure

Also known as: Transamin

Peri-articular group

Intravenous tranexamic acid DRUG

750 mg of IV TXA, prior to deflating the tourniquet and wound closure

Also known as: Transamin

Intravenous group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients with osteoarthritis in need of a TKA

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Orthopaedic department, Thammasat university hospital

Klongluang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (27)

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  PMID: 27455842 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Piya Pinsornsak, MD

  Faculty of Medicine, Thammasat university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 12, 2016
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)