Comparison between infusion and bolus of Tranexamic acid to reduce bleeding in Cyanotic congenital heart disease surgeries.

Comparison between Intravenous Boluses versus Infusion of Tranexamic Acid (TXA) to Reduce Bleeding In Paediatric Cyanotic CHD Surgeries; A Randomized Clinical Control Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001176358

Enrollment

Registered

2017-08-10

Start date

2016-07-16

Completion date

2017-04-03

Last updated

2017-08-21

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

Conditions

None listed

Brief summary

Excessive bleeding in both adults and paediatric cardiac surgery increases morbidity and mortality. Paediatric patients undergoing cardiac surgery are at high risk for intraoperative and postoperative bleeding.Increased bleeding in children exposes them to transfusion of blood and blood products, hence increased risk of complications associated with transfusion. Tranexamic acid is being used to reduce bleeding but there is no specific dose or regimen. We compared two different regimens of Tranexamic acid i.e infusion and bolus to see which is better in terms of Post-operative bleeding, chest closure time and blood products usage.

Interventions

Tranexamic acid Infusion (considered as intervention) - intravenous infusion at 5 mg/kg/hour started induction and continued throughout surgery and ICU stay till post-operative bleeding drops to less than 0.5-1 ml/kg/hour.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

1 Days to 16 Years

Healthy volunteers

Inclusion criteria

• Age group: Neonates to 16 yrs. • Cyanotic Congenital heart surgery. • Use of cardiopulmonary bypass. • First open heart surgery

Exclusion criteria

• Renal dysfunction (Serum creatinine >1.5 mg/dl) • Previous neurological event • Congenital or Acquired bleeding disorder (INR>1.5, H/O Easy bruisebility) • Allergic to tranexamic acid (1ml=50mg test dose to test allergy).

Outcome results