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

NCT03690037 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1089

Last updated 2022-04-15

No results posted yet for this study

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

Interventions

DRUG

Tranexamic Acid 100 MG/ML

Tranexamic Acid: 100 MG/ML Solution for injection

DRUG

Tranexamic Acid 500 MG

Tranexamic Acid: Tranexamic Acid 500mg Tablets

Sponsors & Collaborators

  • Belfast Health and Social Care Trust

    lead OTHER

Principal Investigators

  • David Beverland · Belfast Health and Social Care Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-07
Primary Completion
2018-07-08
Completion
2019-07-08

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690037 on ClinicalTrials.gov