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Tranexamic Acid in Knee Joint Surgery (TRACKS)

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ClinicalTrials.gov Identifier: NCT02278263
Recruitment Status : Unknown
Verified December 2014 by Andrew G Hill, University of Auckland, New Zealand.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Andrew G Hill, University of Auckland, New Zealand

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Tranexamic Acid Drug: Normal saline (0.9% NaCl) Phase 4

Detailed Description:

Postoperative anaemia following elective arthroplasty can lead to prolonged hospital stay, delays in rehabilitation and is often poorly tolerated in patients with cardiovascular disease.(1) Tranexamic acid (TXA) in arthroplasty is used by many orthopaedic surgeons to reduce perioperative blood loss and subsequent transfusion of blood products in elective total hip and knee arthroplasty (THA and TKA). In several reviews, systemic TXA (sTXA) significantly reduces blood loss and transfusion rates when compared to placebo, without an increased risk for venous thromboembolism (VTE).(2-4)

The CRASH-2 study, with over 20,000 randomised trauma patients, has also confirmed the efficacy and safety of TXA in this setting, particularly when given early.(5) The evidence for its use to date is overwhelming and when not contraindicated, should be employed by all arthroplasty units as part of their standard practice. However, despite the vast evidence for its use in arthroplasty some surgeons remain cautious over its safety profile when given systemically. TXA is a synthetic derivative of lysine which is responsible for binding reversibly to plasminogen effectively inhibiting clot degradation.(6) Although, this is not clot promoting, inhibiting clot breakdown theoretically may increase the likelihood of clot formation. This is of real concern for surgeons in patients who have had previous VTE. For this reason, some surgeons have utilised TXA as a topical application directly into the surgical field to reduce systemic absorption and avoid VTE.(7, 8)

TXA administered topically in TKA has also been reported to reduce swelling which may have the advantage of earlier mobility and less pain.(9) In cardiac surgery, TXA has been touted as not only having blood conserving properties via the coagulation pathway but also reduces inflammation via attenuation of the pro-inflammatory cascade.(10, 11)

Based on this rationale, this appears to be a sensible and reasonable route of administration for TXA in this population. However, surgeons should ensure they avoid placing undue risk on patients by altering their use of TXA given the strong evidence for sTXA. Therefore, the purpose of this study is to assess whether topical TXA is effective in reducing blood loss in knee joint replacement surgery, and is as safe and as effective as systemic TXA.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Knee Joint Surgery - a Randomised Controlled Trial
Study Start Date : December 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
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)
Administered in all 3 groups
Other Name: Normal saline

Experimental: Topical
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
Given intravenously or topically
Other Name: Cyclokapron

Drug: Normal saline (0.9% NaCl)
Administered in all 3 groups
Other Name: Normal saline

Experimental: Systemic
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
Given intravenously or topically
Other Name: Cyclokapron

Drug: Normal saline (0.9% NaCl)
Administered in all 3 groups
Other Name: Normal saline




Primary Outcome Measures :
  1. Blood loss [ Time Frame: Post operative day 3 ]

    The loss of Hb (in grams) was then estimated according to the formula:

    Hb(loss)=BV (blood volume) 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, 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



Secondary Outcome Measures :
  1. Pain [ Time Frame: Postoperativley for the first 3 days after surgery, 4 times per day ]
    Using the Numeric rating scale (NRS)

  2. Function [ Time Frame: Preop, 6 weeks and 6 months ]
    Using the Oxford Knee Scores and range of movement (ROM)

  3. Quality of Life [ Time Frame: Preop, 6 weeks and 6 months ]
    Using Short Form Health Survey 12 (SF-12)

  4. Complications [ Time Frame: Postoperatively withn 30 days after surgery ]
    Deep vein thrombosis/pulmonary embolus (DVT/PE), death, myocardial infarction/cerebrovascular accident (MI/CVA), infection (deep and superficial), manipulation under anaesthesia (MUA), urinary tract infection (UTI)

  5. Transfusion rates [ Time Frame: Participants will be followed for the duration of their hospital stay expected to be an average of 3-5 days ]

    Those patients receiving blood products. Standardised protocol is as follows:

    The criterion for transfusion of blood products will be a haemoglobin < 80g/L or a haemoglobin <100g/L in a patient with ischaemic heart disease or with significant symptomatology


  6. Length of stay (LOS) [ Time Frame: Average length of stay is expected to be 3 to 5 days ]
    Day of surgery is counted as Day 0.

  7. Readmission rates [ Time Frame: All readmissions to hospital 30 days after date of surgery ]
    Returning to hospital for >24 hours admission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278263


Contacts
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Contact: Marinus Stowers, MBChB +64 9 2760044 ext 2219 msto062@aucklanduni.ac.nz
Contact: Jacob T Munro, MBChB, FRACS jacob.munro@auckland.ac.nz

Locations
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New Zealand
Auckland Hospital Not yet recruiting
Auckland, New Zealand
Contact: Marinus Stowers, MBChB    2760044 ext 2219    marinus.stowers@middlemore.co.nz   
Manukau Surgery Centre Recruiting
Auckland, New Zealand
Contact: Marinus Stowers, MBChB    276 0044 ext 2219    marinus.stowers@middlemore.co.nz   
North Shore Hospital Recruiting
Auckland, New Zealand
Contact: Marinus Stowers, MBChB    2760044 ext 2219    marinus.stowers@middlemore.co.nz   
Contact: Simon Young, MBChB, FRACS       simon.young@waitematadhb.govt.nz   
Nelson Hospital Not yet recruiting
Nelson, New Zealand
Contact: Marinus Stowers, MBChB    2760044 ext 2219    marinus.stowers@middlemore.co.nz   
Contact: Richard Peterson, FRACS       richard.peterson@nmdhb.govt.nz   
Tauranga Hospital Recruiting
Tauranga, New Zealand
Contact: Marinus Stowers, MBChB    2760044 ext 2219    marinus.stowers@middlemore.co.nz   
Sponsors and Collaborators
Andrew G Hill
Investigators
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Principal Investigator: Jacob T Munro, MBChB, FRACS Department of Surgery, The University of Auckland

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrew G Hill, Professor of Surgery, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02278263     History of Changes
Other Study ID Numbers: TRACKS Study
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Keywords provided by Andrew G Hill, University of Auckland, New Zealand:
tranexamic acid
enhanced recovery
arthroplasty
perioperative care
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants