Osteoarthritis,KneePhase 2NCT03074994

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

A Phase 2 study testing Peri-articular TXA (15 mg/kg), Intraarticular TXA 2 g (40 mL) and TXA combined with multimodal local anesthetic infiltration inject into peri-articular area in people with Osteoarthritis,Knee, run by Thammasat University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 90 years
Conditions the study is for: Osteoarthritis,Knee
What is being tested?: Peri-articular TXA (15 mg/kg), Intraarticular TXA 2 g (40 mL) and TXA combined with multimodal local anesthetic infiltration inject into peri-articular area
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteThailand
Study dates: Oct 2016to Sep 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients with osteoarthritis in need of a TKA

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Piya Pinsornsak, MD contact

pinpiya2003@yahoo.com

Thailand1 site, 1 recruiting

Thammasat university hospital
Pathum Thani, Klongluang, 12120
Piya Pinsornsak, MD, 02-926-9705, pinpiya2003@yahoo.com
Recruiting

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Conditions: Osteoarthritis,Knee
Being tested: 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
Keywords: Tranexamic acid, Peri-articular injection, Intraarticular injection, Total knee arthroplasty, Blood loss
Medical subject headings: Osteoarthritis, Knee, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peri-articular TXA (15 mg/kg)Drug
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
Intraarticular TXA 2 g (40 mL)Drug
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)
TXA combined with multimodal local anesthetic infiltration inject into peri-articular areaProcedure or surgery
(Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation
TXA 40 mL inject into intraaricular knee capsuleProcedure or surgery
after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation

Study groups in NCT03074994
Study group	Role	What they receive
Peri-articular tranexamic acid injection	Experimental	TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area) Receives: Drug: Peri-articular TXA (15 mg/kg); Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area
Intraarticular tranexamic acid injection	Experimental	TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration Receives: Drug: Intraarticular TXA 2 g (40 mL); Procedure: TXA 40 mL inject into intraaricular knee capsule
Control group	No intervention	Don't receive any route of TXA

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes from baseline hemoglobin concentrations
Measured: 48 hours after the operation
Unit of blood transfusion
Measured: 48 hours after the operation

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Sep 2019

First posted9 Mar 2017
Study startOct 2016
Primary completionJun 2019 (estimated)
Study completionSep 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis,KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 108 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03074994
Sponsor's protocol ID: MTU-EC-OT-6-063/59
Status last verified: Jun 2018
First submitted: 20 Nov 2016
Last updated: 24 Apr 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Madjdpour C, Spahn DR. Allogeneic red blood cell transfusions: efficacy, risks, alternatives and indications. Br J Anaesth. 2005 Jul;95(1):33-42. doi: 10.1093/bja/aeh290. Epub 2004 Oct 14.
PubMed 15486006
Fiebig E. Safety of the blood supply. Clin Orthop Relat Res. 1998 Dec;(357):6-18. doi: 10.1097/00003086-199812000-00003.
PubMed 9917695
Heddle NM, Klama LN, Griffith L, Roberts R, Shukla G, Kelton JG. A prospective study to identify the risk factors associated with acute reactions to platelet and red cell transfusions. Transfusion. 1993 Oct;33(10):794-7. doi: 10.1046/j.1537-2995.1993.331094054613.x.
PubMed 8236418
Juelsgaard P, Larsen UT, Sorensen JV, Madsen F, Soballe K. Hypotensive epidural anesthesia in total knee replacement without tourniquet: reduced blood loss and transfusion. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):105-10. doi: 10.1053/rapm.2001.21094.
PubMed 11251132
Sharma V, Fan J, Jerath A, Pang KS, Bojko B, Pawliszyn J, Karski JM, Yau T, McCluskey S, Wasowicz M. Pharmacokinetics of tranexamic acid in patients undergoing cardiac surgery with use of cardiopulmonary bypass. Anaesthesia. 2012 Nov;67(11):1242-50. doi: 10.1111/j.1365-2044.2012.07266.x. Epub 2012 Jul 24.
PubMed 22827564
Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989.
PubMed 22161917
Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.
PubMed 22623147
Zhang H, Chen J, Chen F, Que W. The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2012 Sep;20(9):1742-52. doi: 10.1007/s00167-011-1754-z. Epub 2011 Nov 8.
PubMed 22065294
Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. doi: 10.1177/0310057X0303100507.
PubMed 14601276
Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.
PubMed 23815893
Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
PubMed 25450009
Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
PubMed 21048170
Jain NP, Nisthane PP, Shah NA. Combined Administration of Systemic and Topical Tranexamic Acid for Total Knee Arthroplasty: Can It Be a Better Regimen and Yet Safe? A Randomized Controlled Trial. J Arthroplasty. 2016 Feb;31(2):542-7. doi: 10.1016/j.arth.2015.09.029. Epub 2015 Sep 26.
PubMed 26507526
Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.
PubMed 23886406
Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.
PubMed 23881695

Want to know more?

Piya Pinsornsak, MD

pinpiya2003@yahoo.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis,Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty: A Prospective, Double-Blind Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT03074994
Acronym / sponsor ID: MTU-EC-OT-6-063/59
Conditions: Osteoarthritis,Knee
Keywords: Tranexamic acid, Peri-articular injection, Intraarticular injection, Total knee arthroplasty, Blood loss
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 108 participants (estimated)
Lead sponsor: Thammasat UniversityUniversity, hospital or other
Collaborators: Boontanapibul, Krit, M.D.
Study start: Oct 2016
Primary completion: Jun 2019 (estimated)
Study completion: Sep 2019 (estimated)
First posted: 9 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Peri-articular tranexamic acid injection	Experimental	Drug: Peri-articular TXA (15 mg/kg), Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular areaTXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)
Intraarticular tranexamic acid injection	Experimental	Drug: Intraarticular TXA 2 g (40 mL), Procedure: TXA 40 mL inject into intraaricular knee capsuleTXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration
Control group	No intervention	–Don't receive any route of TXA

Who may qualify

Ages: 40 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients with osteoarthritis in need of a TKA

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Peri-articular tranexamic acid injection
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)	Drug	Intraarticular tranexamic acid injection
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 or surgery	Peri-articular tranexamic acid injection
TXA 40 mL inject into intraaricular knee capsuleafter multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation	Procedure or surgery	Intraarticular tranexamic acid injection

Primary outcome

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

7 secondary outcomes

Tranexamic acid level in blood
Time frame: 2 and 24 hours after the operation
Knee diameter for swelling
Time frame: 24 and 48 hours after the operation
Local soft tissue complications
Time frame: 14 days after the operation
Skin necrosis
Time frame: 24 and 48 hours after the operation
Number of patient with venous thromboembolism
Time frame: 14 days after the operation
Visual Analogue Scales
Time frame: 24 and 48 hours after the operation
Knee flexion angle
Time frame: 24 and 48 hours after the operation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Results publication: PubMed 15486006Madjdpour C, Spahn DR. Allogeneic red blood cell transfusions: efficacy, risks, alternatives and indications. Br J Anaesth. 2005 Jul;95(1):33-42. doi: 10.1093/bja/aeh290. Epub 2004 Oct 14.
Results publication: PubMed 9917695Fiebig E. Safety of the blood supply. Clin Orthop Relat Res. 1998 Dec;(357):6-18. doi: 10.1097/00003086-199812000-00003.
Results publication: PubMed 8236418Heddle NM, Klama LN, Griffith L, Roberts R, Shukla G, Kelton JG. A prospective study to identify the risk factors associated with acute reactions to platelet and red cell transfusions. Transfusion. 1993 Oct;33(10):794-7. doi: 10.1046/j.1537-2995.1993.331094054613.x.
Results publication: PubMed 11251132Juelsgaard P, Larsen UT, Sorensen JV, Madsen F, Soballe K. Hypotensive epidural anesthesia in total knee replacement without tourniquet: reduced blood loss and transfusion. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):105-10. doi: 10.1053/rapm.2001.21094.
Results publication: PubMed 22827564Sharma V, Fan J, Jerath A, Pang KS, Bojko B, Pawliszyn J, Karski JM, Yau T, McCluskey S, Wasowicz M. Pharmacokinetics of tranexamic acid in patients undergoing cardiac surgery with use of cardiopulmonary bypass. Anaesthesia. 2012 Nov;67(11):1242-50. doi: 10.1111/j.1365-2044.2012.07266.x. Epub 2012 Jul 24.
Results publication: PubMed 22161917Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989.
Results publication: PubMed 22623147Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.
Results publication: PubMed 22065294Zhang H, Chen J, Chen F, Que W. The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2012 Sep;20(9):1742-52. doi: 10.1007/s00167-011-1754-z. Epub 2011 Nov 8.
Results publication: PubMed 14601276Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. doi: 10.1177/0310057X0303100507.
Results publication: PubMed 23815893Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.
Results publication: PubMed 25450009Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
Results publication: PubMed 21048170Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Piya Pinsornsak, MD contact

pinpiya2003@yahoo.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Piya Pinsornsak, MD (pinpiya2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline hemoglobin concentrations (time frame: 48 hours after the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03074994, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.