Tranexamic Acid in Knee Joint Surgery

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Total knee joint replacement surgery can lead to significant blood loss, which can affect recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of debate. Growing interest in the topical application of TXA (directly into the surgical wound) has been suggested as an alternative way of administering TXA, and may demonstrate similar effectiveness as when it is given intravenously. Therefore, this multicentred, randomized controlled trial, aims to investigate the safety and effectiveness of both topical and intravenous administrations of TXA in total knee joint surgery. The investigators predict that both routes of administration will demonstrate similar results when compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Andrew G Hill; Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• All patients at the participating sites on the waiting list for a unilateral total knee joint replacement

Exclusion Criteria:

• Patients with a history or risk of thrombosis

• Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis

• Subarachnoid haemorrhage

• Hypersensitivity to tranexamic acid or any of its ingredients.

• Refusal of blood products

• Colour blindness

• Complex hematologic disorders requiring manipulation

• Coagulopathy

• Pregnant and Lactating Women

• Anti-coagulant therapy pre-operatively within 5 days of surgery (warfarin, dabigatran, heparin)

• Severe renal failure (eGFR <29)