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Trial record 40 of 418 for:    TRANEXAMIC ACID

Investigating the Effect of Intravenous and Oral Tranexamic Acid on Blood Loss After Primary Hip and Knee Arthroplasty (TRAC-24)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690037
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

Brief Summary:

Patients having a hip or knee replacement can lose almost a third of their blood during and after the operation. Many patients, especially those who are older will need a blood transfusion, suffer from anaemia, or have a slow recovery after the operation. Tranexamic acid is a medication used to treat or prevent excessive blood loss, but in joint replacements, is only used in patients who are likely to bleed a lot. This trial aims to find out how well tranexamic acid works to reduce blood loss after the operation in a large group of patients having a hip or knee replacement, including those at risk of blood clots. This study also aims to find out how safe tranexamic acid treatment is to use in different patients and the best way to give tranexamic acid (in tablet form or through a drip), as well as how much to give and how long it should be given after an operation. All adults awaiting non-emergency hip or knee replacement surgery will be considered.

Patients who are suitable and agree to take part are randomly placed in one of two treatment groups: receiving tranexamic acid during the hip or knee operation through a drip, or receiving treatment during the hip or knee operation through a drip plus taking a tablet every 8 hours up to 24 hours after the operation. Initially, a no treatment group was included, however, one year after the trial started, the Data Monitoring and Ethics Committee who check safety, advised to stop allocation of patients to the no treatment group.

For all patients, blood loss is recorded up to 48 hours after surgery. Blood samples are also taken in order to measure how well the heart and blood clotting systems are working. If the routine kidney function tests taken before the operation show less than normal function, a lower dose of tranexamic acid is used.

It is expected that patients who receive the tranexamic acid will lose much less blood during and after their operation, and so be less likely to need a blood transfusion, have reduced stress on the heart and have an easier recovery. It is thought that patients with a history of clots are more likely to have another clot when taking tranexamic acid. Therefore, this trial will include these patients to try and find out if this is true as these patients will benefit the most from reduced blood loss.


Condition or disease Intervention/treatment Phase
Primary Total Knee Arthroplasty Primary Total Hip Arthroplasty Drug: Tranexamic Acid 100 MG/ML Drug: Tranexamic Acid 500 MG Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1089 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Phase IV, single centred, open label, parallel group, randomised controlled trial
Masking: None (Open Label)
Masking Description: Not Blinded
Primary Purpose: Treatment
Official Title: Single Centre Randomised Controlled Trial to Assess the Effect of the Addition of Twenty-four Hours of Oral Tranexamic Acid Post-operatively to a Single Intra-operative Intravenous Dose of Tranexamic Acid on Calculated Blood Loss Following Primary Hip and Knee Arthroplasty.
Actual Study Start Date : July 7, 2016
Estimated Primary Completion Date : November 6, 2018
Estimated Study Completion Date : October 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group 1
Intervention Group 1: 1g intravenous Tranexamic Acid 100 milligrams (MG)/ML peri-operatively plus 1g oral Tranexamic Acid 500mg Tablets every 8hrs for up to 24hrs
Drug: Tranexamic Acid 100 MG/ML
Tranexamic Acid: 100 MG/ML Solution for injection
Other Name: TXA

Drug: Tranexamic Acid 500 MG
Tranexamic Acid: Tranexamic Acid 500mg Tablets
Other Name: TXA

Experimental: Intervention Group 2
Intervention Group 2: 1g intravenous Tranexamic Acid 100 MG/ML peri-operatively
Drug: Tranexamic Acid 100 MG/ML
Tranexamic Acid: 100 MG/ML Solution for injection
Other Name: TXA

No Intervention: Control Group 3
Standard care - no TXA



Primary Outcome Measures :
  1. Total Indirect blood loss [ Time Frame: At 48 hours ]
    Volume (ml) of the total indirect blood loss at 48 hours


Secondary Outcome Measures :
  1. Incidence of Post-operative haemoglobin falling below the transfusion trigger [ Time Frame: Prior to discharge, up to 48 hours ]
    Incidence of post-operative haemoglobin falling below the transfusion trigger

  2. Effect of body mass index (BMI) on the volume of indirect blood loss [ Time Frame: At 48 hours post-surgery ]
    Effect of BMI on volume of indirect blood loss at 48 hours post surgery

  3. Change in c-reactive protein [ Time Frame: Pre-surgery to 48 hours post-surgery ]
    Change in c-reactive protein from pre-surgery to 48 hours post surgery

  4. Change in Creatinine level [ Time Frame: pre-surgery to 48 hours post-surgery ]
    Change in creatinine level from pre-surgery to 48 hours post surgery

  5. Mortality [ Time Frame: 90 days and 1 year post surgery ]
    Incidence of mortality at 90 days and 1 year


Other Outcome Measures:
  1. Comparison of intra-operative blood loss between the groups [ Time Frame: At 48 hours post surgery ]
    Comparison of intra-operative blood loss between the groups at 48 hours

  2. Number of wound dressing changes in the 48 hours post surgery [ Time Frame: 48 hours post-surgery ]
    Number of wound dressing changes

  3. The number of requests for Post-operative Troponin levels prior to discharge [ Time Frame: Tested prior to discharge up to Day 4 post-operative ]
    Number of requests (and the result) for post-operative troponin levels

  4. Length of hospital stay after surgery [ Time Frame: Up to 30 days ]
    Length of hospital stay after surgery in days

  5. Incidence of allogenic blood transfusion prior to discharge from hospital [ Time Frame: Tested prior to discharge up to Day 4 post-operative ]
    Incidence of allogenic blood transfusion prior to discharge from hospital

  6. Incidence of allogenic blood transfusion within 90 days of surgery [ Time Frame: 90 days post-surgery ]
    Incidence of allogenic blood transfusion within 90 days of surgery

  7. Incidence of post-operative haemoglobin falling below transfusion trigger without patient being transfused up until time of discharge [ Time Frame: Up to Day 4 post-operative ]
    Incidence of post-operative haemoglobin falling below transfusion trigger without patient being transfused

  8. Incidence of post-operative arrhythmia within 90 days of surgery [ Time Frame: within 90 days of surgery ]
    Incidence of post-operative arrhythmia within 90 days of surgery

  9. Incidence of Pulmonary Embolism (PE) within 90 days of surgery [ Time Frame: within 90 days of surgery ]
    Incidence of Pulmonary Embolism (PE) within 90 days of surgery

  10. Incidence of proximal Deep Vein Thrombosis (DVT) within 90 days of surgery [ Time Frame: within 90 days of surgery ]
    Incidence of proximal Deep Vein Thrombosis (DVT) within 90 days of surgery

  11. Incidence of myocardial infarction within 90 days of surgery [ Time Frame: 90 days post-surgery ]
    Incidence of myocardial infarction within 90 days of surgery

  12. Incidence of stroke within 90 days of surgery [ Time Frame: 90 days post-surgery ]
    Incidence of stroke within 90 days of surgery

  13. Number of emergency hospital admissions or unplanned critical care admissions within 90 days of surgery [ Time Frame: 90 days post-surgery ]
    Number of emergency hospital admissions or unplanned critical care admissions within 90 days of surgery

  14. Number of returns to theatre for wound problems within 90 days of surgery [ Time Frame: 90 days post-surgery ]
    Number of returns to theatre for wound problems within 90 days of surgery

  15. Difference in indirect blood loss at 48 hours between patients on aspirin as a VTE prophylaxis compared with those on clexane [ Time Frame: at 48 hours ]
    Difference in indirect blood loss at 48 hours between patients on aspirin as a VTE prophylaxis compared with those on clexane

  16. Difference in indirect blood loss at 48 hours between patients placed in flexion in a knee jig for 6 hours post-operatively as opposed to those placed in flexion on a pillow [ Time Frame: at 48 hours ]
    Difference in indirect blood loss at 48 hours between patients placed in flexion in a knee jig for 6 hours post-operatively as opposed to those placed in flexion on a pillow

  17. Difference in indirect blood loss at 48 hours between patients in whom a tourniquet was used as compared to those in whom a tourniquet was not used during TKA [ Time Frame: at 48 hours ]
    Difference in indirect blood loss at 48 hours between patients in whom a tourniquet was used as compared to those in whom a tourniquet was not used during TKA

  18. Change on Oxford Hip Score (OHS) or Oxford Knee Score (OKS) from pre surgery to 90 days post-surgery [ Time Frame: from pre surgery to 90 days post-surgery ]
    Change in total score in Oxford Hip Score or Oxford Knee Score which assess function and pain in patients undergoing hip or knee surgery

  19. Change on Oxford Hip Score (OHS) or Oxford Knee Score (OKS) from pre surgery to 1 year post-surgery [ Time Frame: from pre-surgery to 1 year post-surgery ]
    Change in total score in Oxford Hip Score or Oxford Knee Score which assess function and pain in patients undergoing hip or knee surgery

  20. Differences in hospital costs associated with each treatment group [ Time Frame: Up to 90 days ]
    Difference in cost associated with hospital stay between groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Awaiting primary elective hip or knee replacement
  2. ≥ 18 years of age and ≤100 years

Exclusion Criteria:

  1. Patients who do not pass a pre-operative assessment for elective total hip or knee arthroplasty (THA/TKA)
  2. Fractured neck of femur
  3. Haemophiliac or coagulation disorders that require TXA
  4. Allergy to tranexamic acid or any of its excipients
  5. Platelets less than 75,000/mm3 at pre-operative assessment*
  6. Patients on active treatment for venous thromboembolism (VTE) (deep vein thrombosis (DVT), pulmonary embolisms (PE)) within 6 months of surgery*
  7. History of VTE within 6 months of surgery*
  8. Patients who have had a myocardial infarction (MI) within 12 months*
  9. Cardiac stent within 12 months of surgery*
  10. Patients who have had a stroke (cerebrovascular accident (CVA)) or transient ischemic attack (TIA) within 9 months of surgery*
  11. Use of antiplatelet medication within 7 days of surgery* (Does not include aspirin if dose <300mg).
  12. Direct thrombin inhibitors within 2 days of surgery*
  13. Factor Xa inhibitors within 2 days of surgery*
  14. The International normalized ratio (INR) level is greater than or equal to 1.5 in a patient who has stopped warfarin in preparation for surgery
  15. Hepatic failure*
  16. Patients with epilepsy
  17. Patients requiring therapeutic anticoagulation post-operatively e.g. Metallic heart valves.
  18. Pregnant women, women who have not yet reached the menopause (no menses for ≥ 12 months without an alternative medical cause) who test positive for pregnancy or are unwilling to take a pregnancy test prior to trial entry
  19. Patients who have been using Combined hormonal contraception (which includes combined oral contraception (COC), combined contraceptive transdermal patch and vaginal ring) within 4 weeks of surgery*.
  20. Female patients who are breastfeeding
  21. Treated with any other investigational medication or device within 60 days
  22. Patients unable to provide informed consent
  23. Patients who are unable or unwilling to commit to the study schedule of events
  24. Patients unwilling to provide informed consent
  25. Patients who present for simultaneous bilateral THA or TKA
  26. Patients who are on renal dialysis and have an arteriovenous (AV) fistula
  27. Patients who previously have been enrolled in this study

    • These are patients with contra-indications to primary hip or knee replacement.

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): NCT03690037


Locations
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United Kingdom
Primary Joint Unit, Musgrave Park Hospital, BHSCT
Belfast, Northern Ireland, United Kingdom, BT9 7JB
Sponsors and Collaborators
Belfast Health and Social Care Trust
Investigators
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Principal Investigator: David Beverland Belfast Health and Social Care Trust

Publications:
Wishart N, Beaumont R, Young E, Mccormack V, Swanson M. 11th Annual Report- National Joint Registry. 2014;(December 2013).

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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03690037     History of Changes
Other Study ID Numbers: 15039DB - SW
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Requests for data sharing will be reviewed on an individual basis by the Chief Investigator (CI) and Trial Management Group (TMG).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belfast Health and Social Care Trust:
Tranexamic Acid
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants