CompletedPhase 4ACTRN12617001176358

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.


Sponsor

Irfan Akhter

Enrollment

60 participants

Start Date

Jul 16, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 16 Yearss

Inclusion Criteria4

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

Exclusion Criteria4

  • 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).

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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

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.


Locations(1)

Sind, Pakistan

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ACTRN12617001176358