Novel use of tranexamic acid in major joint surgery

Prospective randomised equivalence trial to compare blood loss and transfusion rates for periarticular and intravenous administration of tranexamic acid in primary hip and knee joint arthroplasty.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001043729

Enrollment

100

Registered

2013-09-19

Start date

2014-06-01

Completion date

2015-01-05

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

Major joint surgery is associated with significant blood loss which often requires transfusion. Tranexamic acid is a recommended medication to assist with limiting blood loss. It acts by preventing the breakdown of blood clot. The usual dosage is multiple intravenous injections. The optimal dose is unknown. This study will examine the effects of direct injection of tranexamic acid into the site of surgery and compare this to the intravenous route. The hypothesis is that this will be as effective if not more effective than intravenous use and is easier to administer.

Interventions

1 gram of tranexamic acid directly infiltrated into the periarticular tissues mixed with the standard local anaesthetic solution. The local infiltration analgesic (LIA) mixture consists of 150mls of 0.2% ropivicaine with 5micrograms per ml of adrenaline.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Primary unilateral total hip arthroplasty Primary unilateral total knee arthroplasty

Exclusion criteria

Revision Hip or Knee Arthroplasty Unicompartment (Oxford) knee arthroplasty Cardiac Stents Prior stroke or myocardial infarction History of deep venous thrombosis or pulmonary embolus Any thrombophilia Oral contraceptive pill Pregnancy or breast feeding End stage renal failure Peripheral vascular disease with vascular stents

Outcome results