Investigating the Effect of Intravenous and Oral Tranexamic Acid on Blood Loss After Primary Hip and Knee Arthroplasty

NCT ID: NCT03690037

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1089 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-07
• Study Completion Date: 2019-07-08

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.

Detailed Description

Although numerous studies have demonstrated efficacy in using tranexamic acid (TXA) in primary hip and knee arthroplasty, it has not yet become a recognised standard of care in the United Kingdom (UK). In part, this is because trials to date have excluded many of the patients who could most benefit from a reduced peri-operative blood loss. This trial aims to maximize the potential of TXA by continuing administration post-operatively, at the time of greatest loss. In doing so, the aim is to establish a standardised protocol that can be adopted by other units. Also, despite any published evidence and the excellent safety profile of TXA, there have been concerns about a potential increased risk of venous thrombo-embolism (VTE) which in itself has been a contentious issue in the UK. The exclusion criteria have been adapted in this trial to address these safety concerns.This trial will contribute to establishing the effect of TXA on perioperative blood loss.

Reducing blood loss after hip and knee arthroplasty helps patients avoid anaemia and allogenic blood transfusion with their incumbent risks. TXA is effective intravenously and topically at reducing perioperative bleeding in various surgeries, the evidence in joint arthroplasty is compelling with calculated blood losses reduced by 30% and the need for a transfusion by 50%. However, it remains unclear as to whether extending a dosing regime of TXA beyond the immediate perioperative period would lead to further reductions in blood loss. Oral TXA would be a cheaper and less labour intensive mode of delivery post-operatively than either intravenous bolus or intravenous infusion regimes.

Patients undergoing joint arthroplasty are often elderly with co-morbidities; this frailty makes them particularly vulnerable to the adverse effects of major blood loss. Reducing bleeding in this group is likely to be particularly beneficial to patient outcomes.The majority of blood loss occurs in the first 24 hours post-operatively. A dosing regimen of intravenous TXA eight hourly for twenty-four hours has been suggested. Replacing this with an oral dose would be cheaper, less labour intensive for nursing staff and less disruptive for patients. One gram of oral TXA given 8 hourly for four doses following arthroplasty is consistent with prescribing guidance in the Summary of Product Characteristics (SPC) for local fibrinolysis.There is no evidence in the context of joint replacements to favour either 8 hourly or 6 hourly dosing. Both are licensed regimens as per SPC and therefore an 8 hourly regime is considered less intrusive to the patient.

Intravenous (IV) TXA has an elimination half-life of 3 hours (almost completely excreted unchanged in urine). Five hours after a dose of 10mg/kg IV bolus, the serum level is 5µg/L and it is thought that a level of 10µg/L provides 80% inhibition of fibrinolysis and is considered clinically effective. Oral TXA has a peak level 2 hours following ingestion. By administering the dose in the recovery ward 2 hours following knife to skin (KTS), this will give its peak effect just over 4 hours after the IV dose is administered in both hip and knee arthroplasty.

The aim is to minimise sub therapeutic TXA levels at the time of the highest bleeding risk. Nilsson (1987) noted that after total hip arthroplasty (THA), blood loss from drains was lower following a single 10mg/kg bolus intra-operatively in the first 2 hours but that the drain outputs then equilibrated between the TXA group and the control group after that for the following 10 hours. This supports the current hypothesis that administering further doses of TXA early post-operatively could further reduce blood loss. Also it will be easier to ensure accurate time of the first dose administration in recovery rather than on the ward due to greater staff availability.

This study initially used two tranexamic acid intervention groups (Groups 1 & 2) and one no treatment comparator group (Control Group 3). Although the benefits of using TXA in elective hip and knee arthroplasty to reduce blood loss has been shown, it has not become standard of care in the UK and hence the initial need for the Control Group 3. Following an interim analysis, it was recommended to stop randomisation to Control Group 3.

In addition, this study will incrementally contribute to the growing data relating to use of TXA in patients with a history of VTE. However, to definitively determine what impact TXA has on VTE in the peri-operative period would require a large appropriately powered multi-centre study.

Study Aim and Objectives

This is a Phase IV, single centred, open label, parallel group, randomised controlled trial involving primary hip and knee arthroplasty patients.

The overall aim of this study is to reduce blood loss in THA and Total Knee Arthroplasty (TKA) patients using TXA. While TXA has been shown to reduce blood loss in THA/TKA patients, the optimum method of delivery, optimum number of doses and optimum period of use is not clear. A previous audit of patients under the care of the Chief Investigator demonstrated that 5/6 of the blood loss occurs post wound closure. Therefore, hypothetically if TXA is given to a patient for over 24 hours following surgery it should further reduce blood loss as compared to TXA dosing in the immediate peri-operative period.

-Primary Objective: The primary objective is to determine if the use of oral TXA post-operatively for up to 24 hours will confer a reduction in the calculated blood loss at 48 hours beyond an intra-operative intravenous bolus alone for patients undergoing unilateral primary total hip or knee replacement.

-Secondary Objective: The secondary objective is to determine if the addition of oral TXA post-operatively to an intra-operative intravenous bolus of TXA produces any change in other measurable parameters as compared to those observed either with an intra-operative intravenous bolus alone or no TXA for patients undergoing unilateral primary THA/TKA.

While this study is not powered to answer questions such as whether the use of TXA can lower complications, it is important that complications are reported on. If it was found that using TXA increased the number of complications, this would be a clinically important outcome which should be reported.

Eligible participants were initially allocated to Intervention Group 1 (IV TXA peri-operatively plus 1g oral TXA every 8hrs for up to 24hrs), Intervention Group 2 (IV TXA peri-operatively) or Control Group 3 (standard care) with an allocation ratio of 2:2:1.

Patients with a renal impairment receive a reduced dose dependent on pre-operative serum creatinine.

Following the interim analysis it was recommended to stop randomisation to Control Group 3. Eligible participants are allocated to Intervention Group 1 or Intervention Group 2 with an allocation ratio of 1:1.

Anaesthetists, surgeons, other theatre, recovery and ward staff will not be blinded to the treatment, nor will the study investigators or the patient themselves.

However, the number of patients falling below the transfusion trigger will be blinded.The transfusion trigger will be set as per standardised protocol after consent and prior to randomisation. Therefore, the decision about whether or not to transfuse will not be blinded but the transfusion trigger will be blinded.

Staff in an off-site laboratory who are processing the blood samples will be blinded to the treatment Group allocation.

The TRAC-24 trial initially required a minimum of 1166 patients to be recruited. Recruitment was due to stop when 583 participants had been recruited for both the TKA and THA patients. However, following the interim analysis, randomisation of patients to Control Group 3 was stopped. Recruitment will now continue until a minimum of 932 patients, comprising of 466 TKA and 466 THA, is reached.

Conditions

Primary Total Knee Arthroplasty; Primary Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Tranexamic Acid 100 MG/ML

Intervention Type: DRUG

Tranexamic Acid: 100 MG/ML Solution for injection

Tranexamic Acid 500 MG

Intervention Type: DRUG

Tranexamic Acid: Tranexamic Acid 500mg Tablets

Intervention Group 2

Intervention Group 2: 1g intravenous Tranexamic Acid 100 MG/ML peri-operatively

Group Type: EXPERIMENTAL

Tranexamic Acid 100 MG/ML

Intervention Type: DRUG

Tranexamic Acid: 100 MG/ML Solution for injection

Control Group 3

Standard care - no TXA

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tranexamic Acid 100 MG/ML

Tranexamic Acid: 100 MG/ML Solution for injection

Intervention Type: DRUG

Tranexamic Acid 500 MG

Tranexamic Acid: Tranexamic Acid 500mg Tablets

Intervention Type: DRUG

Other Intervention Names

TXA; TXA

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Beverland

Role: PRINCIPAL_INVESTIGATOR

Belfast Health and Social Care Trust

Locations

Primary Joint Unit, Musgrave Park Hospital, BHSCT

Belfast, Northern Ireland, United Kingdom

Countries

United Kingdom

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Other Identifiers

15039DB - SW

Identifier Type: -

Identifier Source: org_study_id