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NCT03690037 Clinical Trial

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

Primary Total Hip Arthroplasty Clinical Trial

— TRAC-24  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03690037
Other study ID # 15039DB - SW
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 7, 2016
Est. completion date July 8, 2019

Study information
Verified date April 2022
Source Belfast Health and Social Care Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic Acid 100 MG/ML
Tranexamic Acid: 100 MG/ML Solution for injection
• Tranexamic Acid 500 MG
Tranexamic Acid: Tranexamic Acid 500mg Tablets

Locations
Country Name City State
United Kingdom Primary Joint Unit, Musgrave Park Hospital, BHSCT Belfast Northern Ireland

Sponsors (1)
Lead Sponsor Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (36)

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Outcome
Type Measure Description Time frame Safety issue
Other Comparison of intra-operative blood loss between the groups Comparison of intra-operative blood loss between the groups at 48 hours At 48 hours post surgery
Other Number of wound dressing changes in the 48 hours post surgery Number of wound dressing changes 48 hours post-surgery
Other The number of requests for Post-operative Troponin levels prior to discharge Number of requests (and the result) for post-operative troponin levels Tested prior to discharge up to Day 4 post-operative
Other Length of hospital stay after surgery Length of hospital stay after surgery in days Up to 30 days
Other Incidence of allogenic blood transfusion prior to discharge from hospital Incidence of allogenic blood transfusion prior to discharge from hospital Tested prior to discharge up to Day 4 post-operative
Other Incidence of allogenic blood transfusion within 90 days of surgery Incidence of allogenic blood transfusion within 90 days of surgery 90 days post-surgery
Other Incidence of post-operative haemoglobin falling below transfusion trigger without patient being transfused up until time of discharge Incidence of post-operative haemoglobin falling below transfusion trigger without patient being transfused Up to Day 4 post-operative
Other Incidence of post-operative arrhythmia within 90 days of surgery Incidence of post-operative arrhythmia within 90 days of surgery within 90 days of surgery
Other Incidence of Pulmonary Embolism (PE) within 90 days of surgery Incidence of Pulmonary Embolism (PE) within 90 days of surgery within 90 days of surgery
Other Incidence of proximal Deep Vein Thrombosis (DVT) within 90 days of surgery Incidence of proximal Deep Vein Thrombosis (DVT) within 90 days of surgery within 90 days of surgery
Other Incidence of myocardial infarction within 90 days of surgery Incidence of myocardial infarction within 90 days of surgery 90 days post-surgery
Other Incidence of stroke within 90 days of surgery Incidence of stroke within 90 days of surgery 90 days post-surgery
Other Number of emergency hospital admissions or unplanned critical care admissions within 90 days of surgery Number of emergency hospital admissions or unplanned critical care admissions within 90 days of surgery 90 days post-surgery
Other Number of returns to theatre for wound problems within 90 days of surgery Number of returns to theatre for wound problems within 90 days of surgery 90 days post-surgery
Other Difference in indirect blood loss at 48 hours between patients on aspirin as a VTE prophylaxis compared with those on clexane Difference in indirect blood loss at 48 hours between patients on aspirin as a VTE prophylaxis compared with those on clexane at 48 hours
Other 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 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 at 48 hours
Other 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 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 at 48 hours
Other Change on Oxford Hip Score (OHS) or Oxford Knee Score (OKS) 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 from pre surgery to 90 days post-surgery
Other Change on Oxford Hip Score (OHS) or Oxford Knee Score (OKS) 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 from pre-surgery to 1 year post-surgery
Other Differences in hospital costs associated with each treatment group Difference in cost associated with hospital stay between groups Up to 90 days
Primary Total Indirect blood loss Volume (ml) of the total indirect blood loss at 48 hours At 48 hours
Secondary Incidence of Post-operative haemoglobin falling below the transfusion trigger Incidence of post-operative haemoglobin falling below the transfusion trigger Prior to discharge, up to 48 hours
Secondary Effect of body mass index (BMI) on the volume of indirect blood loss Effect of BMI on volume of indirect blood loss at 48 hours post surgery At 48 hours post-surgery
Secondary Change in c-reactive protein Change in c-reactive protein from pre-surgery to 48 hours post surgery Pre-surgery to 48 hours post-surgery
Secondary Change in Creatinine level Change in creatinine level from pre-surgery to 48 hours post surgery pre-surgery to 48 hours post-surgery
Secondary Mortality Incidence of mortality at 90 days and 1 year 90 days and 1 year post surgery
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