Tranexamic acid Trial Intravenous versus Intra articular Tranexamic acid in Primary Hip Arthroplasty: A Prospective Randomised Double Blinded non Inferiority Trial

Effect of Intravenous versus Intra articular Tranexamic acid on haemoglobin levels in patients undergoing primary Hip Arthroplasty A randomised Double blinded non inferiority trial. .

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000907448

Acronym

Tranexamic acid in Hip study IV versus Intra articular. TAHIVIA

Enrollment

Registered

2016-07-08

Start date

2016-06-17

Completion date

Unknown

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

This is a randomised study to determine dosing methods of administering Tranexamic acid a drug used to reduce bleeding in Hip replacement surgery. The purpose of the study is to determine if the drug is as effective giving it via Intravenous route or Intra articular route direct into the hip capsule.

Interventions

At Induction patients are randomised into Group A or B. Group A 15mg /kg IV infusion of Tranexamic acid given IV at induction and then at 8 hours and 16 hours post surgery. Group B Intra articular dose of Tranexamic acid given in 40 mls of Normal Saline at 15mg.kg into the capsule prior to skin closure then followed by Normal Saline 100mls at 8 and 16 hours post surgery.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Primary Hip arthroplasty due to osteoarthritis

Exclusion criteria

Pregnant and lactating women. Renal Impairment (Creatinine> 120mmol/L) Active intravascular clotting or DVT tendencies. Cognitive impairment. Hypersensitivity to Tranexamic acid.

Outcome results