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

NCT03690037 | Completed Phase 4 DMC

• 1 other identifier: 15039DB - SW
• Study Type: interventional
• Target: 1,089
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Total Knee Arthroplasty; Primary Total Hip Arthroplasty

Keywords

Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Total Indirect blood loss

  Volume (ml) of the total indirect blood loss at 48 hours

  At 48 hours

Secondary Outcomes (5)

• Incidence of Post-operative haemoglobin falling below the transfusion trigger

  Prior to discharge, up to 48 hours

• Effect of body mass index (BMI) on the volume of indirect blood loss

  At 48 hours post-surgery

• Change in c-reactive protein

  Pre-surgery to 48 hours post-surgery

• Change in Creatinine level

  pre-surgery to 48 hours post-surgery

• Mortality

  90 days and 1 year post surgery

Other Outcomes (20)

• Comparison of intra-operative blood loss between the groups

  At 48 hours post surgery

• Number of wound dressing changes in the 48 hours post surgery

  48 hours post-surgery

• The number of requests for Post-operative Troponin levels prior to discharge

  Tested prior to discharge up to Day 4 post-operative

Study Arms (3)

Intervention Group 1

EXPERIMENTAL

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; Drug: Tranexamic Acid 500 MG

Intervention Group 2

EXPERIMENTAL

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

Drug: Tranexamic Acid 100 MG/ML

Control Group 3

NO INTERVENTION

Standard care - no TXA

Interventions

Tranexamic Acid 100 MG/ML DRUG

Tranexamic Acid: 100 MG/ML Solution for injection

Also known as: TXA

Intervention Group 1; Intervention Group 2

Tranexamic Acid 500 MG DRUG

Tranexamic Acid: Tranexamic Acid 500mg Tablets

Also known as: TXA

Intervention Group 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Awaiting primary elective hip or knee replacement
• ≥ 18 years of age and ≤100 years

You may not qualify if:

• Patients who do not pass a pre-operative assessment for elective total hip or knee arthroplasty (THA/TKA)
• Fractured neck of femur
• Haemophiliac or coagulation disorders that require TXA
• Allergy to tranexamic acid or any of its excipients
• Platelets less than 75,000/mm3 at pre-operative assessment\*
• Patients on active treatment for venous thromboembolism (VTE) (deep vein thrombosis (DVT), pulmonary embolisms (PE)) within 6 months of surgery\*
• History of VTE within 6 months of surgery\*
• Patients who have had a myocardial infarction (MI) within 12 months\*
• Cardiac stent within 12 months of surgery\*
• Patients who have had a stroke (cerebrovascular accident (CVA)) or transient ischemic attack (TIA) within 9 months of surgery\*
• Use of antiplatelet medication within 7 days of surgery\* (Does not include aspirin if dose \<300mg).
• Direct thrombin inhibitors within 2 days of surgery\*
• Factor Xa inhibitors within 2 days of surgery\*
• 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
• Hepatic failure\*

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (1)

Primary Joint Unit, Musgrave Park Hospital, BHSCT

Belfast, Northern Ireland, BT9 7JB, United Kingdom

Location

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MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• David Beverland

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Phase IV, single centred, open label, parallel group, randomised controlled trial

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: October 1, 2018
• Study Start: July 7, 2016
• Primary Completion: July 8, 2018
• Study Completion: July 8, 2019
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

GB (1)