NCT03074994

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 24, 2019

Status Verified

June 1, 2018

Enrollment Period

2.7 years

First QC Date

November 20, 2016

Last Update Submit

April 23, 2019

Conditions

Osteoarthritis,Knee

Keywords

Tranexamic acidPeri-articular injectionIntraarticular injectionTotal knee arthroplastyBlood loss

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline hemoglobin concentrations

    48 hours after the operation

  • Unit of blood transfusion

    48 hours after the operation

Secondary Outcomes (7)

  • Tranexamic acid level in blood

    2 and 24 hours after the operation

  • Knee diameter for swelling

    24 and 48 hours after the operation

  • Local soft tissue complications

    14 days after the operation

  • Skin necrosis

    24 and 48 hours after the operation

  • Number of patient with venous thromboembolism

    14 days after the operation

  • +2 more secondary outcomes

Study Arms (3)

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)

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

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

Interventions

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

Peri-articular tranexamic acid injection
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)

Intraarticular tranexamic acid injection
TXA combined with multimodal local anesthetic infiltration inject into peri-articular areaPROCEDURE

(Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation

Peri-articular tranexamic acid injection
TXA 40 mL inject into intraaricular knee capsulePROCEDURE

after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation

Intraarticular tranexamic acid injection

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • Preoperative hemoglobin \<10 g/dL or a platelet count \< 140,000 /uL3
  • Allergy to TXA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat university hospital

Pathum Thani, Klongluang, 12120, Thailand

RECRUITING

Related Publications (20)

  • 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.

    PMID: 15486006RESULT

  • Fiebig E. Safety of the blood supply. Clin Orthop Relat Res. 1998 Dec;(357):6-18. doi: 10.1097/00003086-199812000-00003.

    PMID: 9917695RESULT

  • 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.

    PMID: 8236418RESULT

  • 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.

    PMID: 11251132RESULT

  • 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.

    PMID: 22827564RESULT

  • 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.

    PMID: 22161917RESULT

  • 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.

    PMID: 22623147RESULT

  • 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.

    PMID: 22065294RESULT

  • 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.

    PMID: 14601276RESULT

  • 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.

    PMID: 23815893RESULT

  • 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.

    PMID: 25450009RESULT

  • 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.

    PMID: 21048170RESULT

  • 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.

    PMID: 26507526RESULT

  • 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.

    PMID: 23886406RESULT

  • 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.

    PMID: 23881695RESULT

  • Winter SF, Santaguida C, Wong J, Fehlings MG. Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review. Global Spine J. 2016 May;6(3):284-95. doi: 10.1055/s-0035-1563609. Epub 2015 Sep 21.

    PMID: 27099820RESULT

  • Pinsornsak P, Rojanavijitkul S, Chumchuen S. Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2016 Jul 26;17:313. doi: 10.1186/s12891-016-1176-7.

    PMID: 27455842RESULT

  • Callaghan JJ, O'Rourke MR, Liu SS. Blood management: issues and options. J Arthroplasty. 2005 Jun;20(4 Suppl 2):51-4. doi: 10.1016/j.arth.2005.03.018.

    PMID: 15991130RESULT

  • Sa-ngasoongsong P, Chanplakorn P, Wongsak S, Uthadorn K, Panpikoon T, Jittorntam P, Aryurachai K, Angchaisukisiri P, Kawinwonggowit V. An In Vivo Study of Low-Dose Intra-Articular Tranexamic Acid Application with Prolonged Clamping Drain Method in Total Knee Replacement: Clinical Efficacy and Safety. Biomed Res Int. 2015;2015:164206. doi: 10.1155/2015/164206. Epub 2015 Oct 25.

    PMID: 26583092RESULT

  • Chang CH, Chang Y, Chen DW, Ueng SW, Lee MS. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1552-7. doi: 10.1007/s11999-013-3446-0. Epub 2014 Jan 3.

    PMID: 24385043RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeHemorrhage

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Piya Pinsornsak, MD

CONTACT

pinpiya2003@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2016

First Posted

March 9, 2017

Study Start

October 1, 2016

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

April 24, 2019

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)