Tranexamic Acid in Lower Limb Arthroplasty Pilot Trial

The Tranexamic Acid in Lower Limb Arthroplasty Pilot Trial - a pilot trial to examine the feasibility of extension of trial methodology to a large multi-centre randomised controlled trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000323729

Acronym

TALLAS

Enrollment

140

Registered

2013-03-22

Start date

2013-05-01

Completion date

2016-08-01

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 aim of this pilot trial is to evaluate the feasibility of conducting a large multi-centre trial which will investigate the efficacy and safety of tranexamic acid in patients undergoing lower-limb arthroplasty. Tranexamic acid has been approved for use in lower limb arthroplasty in Australia. Although there is evidence to support its efficacy in reducing bleeding, trials examining the incidence of uncommon but serious thrombotic complications in patients receiving TXA for arthroplasty procedures have been small and heterogeneous. A large randomised controlled trial is required, and this pilot study is designed to enable the refining of trial methodology and to determine the feasibility of conducting trial procedures in a smaller group.

Interventions

Tranexamic acid - 15mg/kg given intravenously at 50mg/min at skin incision (for total hip replacement) or just prior to tourniquet release (for total knee replacement) and repeated at 8 and 16 hours post-operatively.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

>45 years of age Undergoing primary or revision total knee or hip replacement At least one night inpatient stay

Exclusion criteria

Poor English language comprehension Inability to obtain informed consent Active thrombo-embolic disease such as DVT, PE, or cerebral thrombosis History of postoperative or spontaneous DVT, pulmonary embolism, spontaneous arterial thrombosis or familial hypercoagulability End-stage renal failure Recent haematuria Contraindication or allergy to TXA Patients who have received TXA or DDAVP in the last 7 days Pregnancy Oral contraceptive (other than low dose Progesterone only)

Outcome results