Tranexamic Acid in Knee Joint Surgery

NCT02278263 | Completed Phase 4 Results

• 1 other identifier: TRACKS Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

Total knee joint replacement surgery can lead to significant blood loss, which can affect recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of debate. Growing interest in the topical application of TXA (directly into the surgical wound) has been suggested as an alternative way of administering TXA, and may demonstrate similar effectiveness as when it is given intravenously. Therefore, this multicentred, randomized controlled trial, aims to investigate the safety and effectiveness of both topical and intravenous administrations of TXA in total knee joint surgery. The investigators predict that both routes of administration will demonstrate similar results when compared to placebo.

Conditions

Osteoarthritis

Keywords

tranexamic acid; enhanced recovery; arthroplasty; perioperative care

Outcome Measures

Primary Outcomes (1)

• Blood Loss

  The loss of haemoglobin (Hb) was then estimated according to the formula: Hb(loss) = Blood volume (BV) x (Hbi-Hbe) x 0.001+Hbt where Hb (loss) (g) is the amount of Hb lost, Hbi (g/L) the Hb concentration before surgery, Hbe (g/L) is the Hbe concentration on the third day after surgery, and Hbt (g) is the total amount of allogeneic Hb transfused. A unit of banked blood is considered to contain a minimum of 40g Hb (Blood component data sheet, New Zealand Blood Services \[NZBS\]). All units of blood are processed and stored in a nationally standardised manner. The blood loss (ml) was related to the patient's preoperative Hb value (g/L): Blood loss =1000 x Hb(loss) /Hbi

  Post operative day 3

Secondary Outcomes (6)

• Number of Participants Experiencing Symptomatic Venothromboembolic (VTE) Disease

  Postoperatively within 30 days after surgery

• Number of Participants Receiving Allogenic Blood Transfusion

  Participants will be followed for the duration of their hospital stay expected to be an average of 3-5 days

• Length of Stay (LOS)

  Average length of stay is expected to be 3 to 5 days

• Range of Passive Flexion

  Days 1-3

• Range of Active Flexion

  Days 1-3

Study Arms (3)

Control

PLACEBO COMPARATOR

Application of 20ml of normal saline (NaCl 0.9%) topically after implantation of prosthesis and left to sit for two minutes, excess carefully suctioned followed by standard closure with no drains; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.

Drug: Normal saline (0.9% NaCl)

Topical

EXPERIMENTAL

Application of 1.5g in 20ml tranexamic acid topically after implantation of prosthesis with excess carefully suctioned followed by standard closure with no drains; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.

Drug: Tranexamic Acid; Drug: Normal saline (0.9% NaCl)

Systemic

EXPERIMENTAL

Application of 20ml of normal saline topically after implantation of prosthesis with excess carefully suctioned followed by standard closure with no drains; Application of tranexamic acid intravenously (1.5g/15ml) at the same time prior to release of tourniquet

Drug: Tranexamic Acid; Drug: Normal saline (0.9% NaCl)

Interventions

Tranexamic Acid DRUG

Given intravenously or topically

Also known as: Cyclokapron

Systemic; Topical

Normal saline (0.9% NaCl) DRUG

Administered in all 3 groups

Also known as: Normal saline

Control; Systemic; Topical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients at the participating sites on the waiting list for a unilateral total knee joint replacement

You may not qualify if:

• Patients with a history or risk of thrombosis
• Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis
• Subarachnoid haemorrhage
• Hypersensitivity to tranexamic acid or any of its ingredients.
• Refusal of blood products
• Colour blindness
• Complex hematologic disorders requiring manipulation
• Coagulopathy
• Pregnant and Lactating Women
• Anti-coagulant therapy pre-operatively within 5 days of surgery (warfarin, dabigatran, heparin)
• Severe renal failure (eGFR \<29)

Sponsors & Collaborators

• Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS: lead

Study Sites (5)

Auckland Hospital

Auckland, New Zealand

Location

Manukau Surgery Centre

Auckland, New Zealand

Location

North Shore Hospital

Auckland, New Zealand

Location

Nelson Hospital

Nelson, New Zealand

Location

Tauranga Hospital

Tauranga, New Zealand

Location

Related Publications (12)

• Carson JL, Duff A, Berlin JA, Lawrence VA, Poses RM, Huber EC, O'Hara DA, Noveck H, Strom BL. Perioperative blood transfusion and postoperative mortality. JAMA. 1998 Jan 21;279(3):199-205. doi: 10.1001/jama.279.3.199.

  PMID: 9438739 BACKGROUND

• 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: 22161917 BACKGROUND

• Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984.

  PMID: 21196541 BACKGROUND

• Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184.

  PMID: 23651507 BACKGROUND

• CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.

  PMID: 21439633 BACKGROUND

• Williams-Johnson JA, McDonald AH, Strachan GG, Williams EW. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2) A randomised, placebo-controlled trial. West Indian Med J. 2010 Dec;59(6):612-24.

  PMID: 21702233 BACKGROUND

• Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.

  PMID: 23541868 BACKGROUND

• Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on transfusion rate in primary total hip arthroplasty. J Arthroplasty. 2014 Feb;29(2):387-9. doi: 10.1016/j.arth.2013.05.026. Epub 2013 Jun 21.

  PMID: 23790499 BACKGROUND

• Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.

  PMID: 21253725 BACKGROUND

• Later AF, Sitniakowsky LS, van Hilten JA, van de Watering L, Brand A, Smit NP, Klautz RJ. Antifibrinolytics attenuate inflammatory gene expression after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Jun;145(6):1611-6, 1616.e1-4. doi: 10.1016/j.jtcvs.2012.11.042. Epub 2013 Jan 16.

  PMID: 23332183 BACKGROUND

• Robertshaw HJ. An anti-inflammatory role for tranexamic acid in cardiac surgery? Crit Care. 2008;12(1):105. doi: 10.1186/cc6210. Epub 2008 Jan 16.

  PMID: 18254939 BACKGROUND

• Stowers MDJ, Aoina J, Vane A, Poutawera V, Hill AG, Munro JT. Tranexamic Acid in Knee Surgery Study-A Multicentered, Randomized, Controlled Trial. J Arthroplasty. 2017 Nov;32(11):3379-3384. doi: 10.1016/j.arth.2017.05.058. Epub 2017 Jun 9.

  PMID: 28662956 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Marinus Stowers
• Organization: Ko Awatea

msto062@aucklanduni.ac.nz

+64 276 0044

Study Officials

• Jacob T Munro, MBChB, FRACS

  Department of Surgery, The University of Auckland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: October 29, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 20, 2020
• Results First Posted: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (5)