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Osteoarthritis, KneePhase 2NCT02829346

Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

A Phase 2 study testing Peri-articular tranexamic acid and Intravenous tranexamic acid in people with Osteoarthritis, Knee, run by Thammasat University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Peri-articular tranexamic acid and Intravenous tranexamic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteThailand
Study dates
Oct 2012to Oct 2013
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Orthopaedic department, Thammasat university hospital

    Klongluang, Changwat Pathum Thani, 12120

Other trials in Thailand

About this study

Official title: Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty: A Randomized Controlled Trial

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.

Read the 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.

Being tested
Peri-articular tranexamic acid, Intravenous tranexamic acid
Keywords
Tranexamic acid, Peri-articular injection, Total knee arthroplasty, Blood loss, Osteoarthritis, Knee
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 tranexamic acidDrug

    Also called Transamin

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

  • Intravenous tranexamic acidDrug

    Also called Transamin

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

Study groups in NCT02829346
Study groupRoleWhat they receive
Peri-articular groupExperimentalPatients 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.
Receives: Drug: Peri-articular tranexamic acid
Intravenous groupActive comparatorPatients 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.
Receives: Drug: Intravenous tranexamic acid

What is being measured

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

  1. The volume of postoperative blood loss in the drain

    Measured: 48 hours after the operation

  2. Changes from baseline hemoglobin concentrations

    Measured: 48 hours after the operation

  3. unit of blood transfusion

    Measured: 48 hours after the operation

Secondary outcomes (2)

  1. Knee diameter for swelling

    Measured: At 24 and 48 hours after the operation

  2. number of patient with venous thromboembolism

    Measured: At 14 days after the operation

Timeline

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

  1. First posted12 Jul 2016 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02829346
Sponsor's protocol ID
MTU-EC-OT-0-096/54
Status last verified
Jul 2016
First submitted
5 Jul 2016
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Sinclair KC, Clarke HD, Noble BN. Blood management in total knee arthroplasty: a comparison of techniques. Orthopedics. 2009 Jan;32(1):19. doi: 10.3928/01477447-20090101-21.

    PubMed 19226044

  • Gonzalez-Porras JR, Colado E, Conde MP, Lopez T, Nieto MJ, Corral M. An individualized pre-operative blood saving protocol can increase pre-operative haemoglobin levels and reduce the need for transfusion in elective total hip or knee arthroplasty. Transfus Med. 2009 Feb;19(1):35-42. doi: 10.1111/j.1365-3148.2009.00908.x.

    PubMed 19302453

  • Parvizi J, Diaz-Ledezma C. Total knee replacement with the use of a tourniquet: more pros than cons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):133-4. doi: 10.1302/0301-620X.95B11.32903.

    PubMed 24187371

  • Sabatini L, Trecci A, Imarisio D, Uslenghi MD, Bianco G, Scagnelli R. Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty. J Orthop Traumatol. 2012 Sep;13(3):145-51. doi: 10.1007/s10195-012-0198-7. Epub 2012 May 16.

    PubMed 22588333

  • Pitta M, Zawadsky M, Verstraete R, Rubinstein A. Intravenous administration of tranexamic acid effectively reduces blood loss in primary total knee arthroplasty in a 610-patient consecutive case series. Transfusion. 2016 Feb;56(2):466-71. doi: 10.1111/trf.13354. Epub 2015 Oct 28.

    PubMed 26509250

  • 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

  • Aggarwal AK, Singh N, Sudesh P. Topical vs Intravenous Tranexamic Acid in Reducing Blood Loss After Bilateral Total Knee Arthroplasty: A Prospective Study. J Arthroplasty. 2016 Jul;31(7):1442-8. doi: 10.1016/j.arth.2015.12.033. Epub 2015 Dec 21.

    PubMed 26947543

  • Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res. 1997 Feb 1;85(3):195-206. doi: 10.1016/s0049-3848(97)00004-2.

    PubMed 9058494

  • Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.

    PubMed 10400410

  • Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg. 2010 Mar;18(3):132-8.

    PubMed 20190103

  • Kluft C, Verheijen JH, Jie AF, Rijken DC, Preston FE, Sue-Ling HM, Jespersen J, Aasen AO. The postoperative fibrinolytic shutdown: a rapidly reverting acute phase pattern for the fast-acting inhibitor of tissue-type plasminogen activator after trauma. Scand J Clin Lab Invest. 1985 Nov;45(7):605-10. doi: 10.3109/00365518509155267.

    PubMed 3934744

  • Murphy WG, Davies MJ, Eduardo A. The haemostatic response to surgery and trauma. Br J Anaesth. 1993 Feb;70(2):205-13. doi: 10.1093/bja/70.2.205. No abstract available.

    PubMed 7679584

  • Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.

    PubMed 21512813

  • Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006 Mar;13(2):106-10. doi: 10.1016/j.knee.2005.11.001. Epub 2006 Feb 17.

    PubMed 16487712

  • Ortega-Andreu M, Perez-Chrzanowska H, Figueredo R, Gomez-Barrena E. Blood loss control with two doses of tranexamic Acid in a multimodal protocol for total knee arthroplasty. Open Orthop J. 2011 Mar 16;5:44-8. doi: 10.2174/1874325001105010044.

    PubMed 21552468

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peri-articular tranexamic acid and Intravenous tranexamic acid in people with Osteoarthritis, Knee, run by Thammasat University at 1 site in Thailand.

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 11 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: finished, as of the sponsor's last update on 12 Jul 2016. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The volume of postoperative blood loss in the drain (time frame: 48 hours after the operation). The study lists 3 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 NCT02829346, which also lists 27 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 12 Jul 2016.

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