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Comparison of different modes of tranexamic acid administration in patients undergoing total knee arthroplasty.

Effect of intravenous versus intra-articular tranexamic acid on haemoglobin drop and blood loss in patients undergoing total knee arthroplasty - a randomised controlled trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000582651
Acronym
NIL
Enrollment
183
Registered
2014-05-30
Start date
2014-07-16
Completion date
2014-12-16
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to analyze the effects of topical tranexamic acid in total knee arthroplasty and to compare it with intravenous tranexamic acid. The study is based on the hypothesis that toipical/intrarticular tranexamic acid is more not inferior in reducing blood loss in total knee arthroplasty and is safer as compared to intravenous total knee arthroplasty.

Interventions

Tranexamic acid. Patients will be assigned to one of 2 treatment groups: 1. Group 1 (Intra-articular TXA group) will receive 100 ml of Saline intravenously, 5 minutes before incision, 3000mg (30ml) of TXA injected in to the knee joint after wound closure and two doses of 100 ml of Saline intra-venously at 8 hourly intervals post-operatively. 2. Group 2 (Intravenous TXA group) will receive 1000mg of TXA in 100ml Saline intravenously 5 minutes before incision and 30ml of Saline injected in to th

Tranexamic acid. Patients will be assigned to one of 2 treatment groups: 1. Group 1 (Intra-articular TXA group) will receive 100 ml of Saline intravenously, 5 minutes before incision, 3000mg (30ml) of TXA injected in to the knee joint after wound closure and two doses of 100 ml of Saline intra-venously at 8 hourly intervals post-operatively. 2. Group 2 (Intravenous TXA group) will receive 1000mg of TXA in 100ml Saline intravenously 5 minutes before incision and 30ml of Saline injected in to the knee joint after wound closure to make the group comparative with Group 1 and also provide a tamponade effect. Another 1000mg dose of TXA (in 100ml Normal Saline over 15 minutes) will be repeated at 8 hourly intervals post-operatively for another two doses. Patients undergoing primary total knee arthroplasty will be invited to take part in the study and informed written consent will be obtained from willing participants. Patients undergoing bilateral TKA, those with history of thromboembolic events (deep vein thrombosis, pulmonary embolism or cerebrovascular accident), renal dysfunction (plasma Creatinine level >130 mmol/L) or coagulopathy (INR > 1.4) will be excluded. Also patients with pre-operative anemia (Hb < 120 for females and Hb < 130 for males) will be excluded.

Sponsors

SAMUEL J MACDESSI
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. All the patients undergoing total knee arthroplasty under the principal investigators. 2. Able to give consent for the study.

Exclusion criteria

1. Inflammatory arthropathy. 2. Patients currently on warfarin (Coumadin) 3.Patients on antiplatelet therapy (excluding aspirin) 4.Bleeding diathesis 5.Haematological dysfunction/Abnormal coagulation studies 6. Patients requiring lateral release, synovectomy, or removal of existing hardware during their procedure 7. Renal or liver disease 8. Previous thromboembolic disease 9. Disturbance of colour vision 10.Stroke 11. Pre-operative anemia (Hb < 120 for females and Hb < 130 for males).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026