A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery
Condition: Pediatric Cardiac Surgery; Complication of Extracorporeal Circulation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolyntic
      drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing
      pediatric cardiac surgery.
    

Detailed description: 
      Bleeding under cardiopulmonary bypass (CPB) is one of the most common complications in
      patients undergoing pediatric cardiac surgery. The inflammatory response produced during and
      after CPB is a factor that adds significantly to the morbidity after cardiac surgery. A
      number of factors have been shown to be involved inducing the inflammatory response. These
      include complement system activation3 and activation of inflammatory cytokines, especially
      IL-1 IL-64, IL-8 and TNF alpha.

      Tranexamic Acid (TXA) and Epsilon-Aminocaproic Acid (EACA) are lysine analogues frequently
      used as anti-fibrinolytic agents in patients undergoing CPB. Many authors have highlighted
      the role of TXA in reducing blood loss and blood transfusion during and after CPB. Role of
      EACA and aprotinin in decreasing pro-inflammatory response during and after CPB has been well
      documented in adult literature. Patients undergoing redo sternotomy have higher inflammatory
      response as compared to patients undergoing first cardiac surgery. It has also been shown
      that the TXA can reduce the inflammatory response after CPB by acting directly or indirectly
      on the inflammatory cytokines.

      There are no studies directly comparing the anti-inflammatory properties of EACA and TXA in
      the pediatric population undergoing CPB. In our institution, EACA is used as the standard of
      practice to reduce the blood loss during pediatric cardiac surgeries, but the investigators
      have now started using TXA more recently.

      The aim of this study is to compare the anti-inflammatory and anti-fibrinolytic properties of
      these two anti-fibrinolytic agents in pediatric patients undergoing CBP for cardiac surgery.

      Hypothesis: Tranexamic acid (TXA) has better anti-inflammatory profile as compared to €-Amino
      Caproic Acid (EACA) which may help in reducing blood loss, renal injury, hepatic injury and
      blood transfusion during and after CPB

      Specific Objectives: During redo sternotomy procedures there is significant anti-inflammatory
      response which occurs and plays a role in increasing amount chest tube output, blood loss,
      renal injury, hepatic injury and ultimately patient morbidity and/or mortality. The proposed
      study will help to know if antifibrinolytic agents are beneficial in reducing the
      anti-inflammatory response produced and which of the two drugs (EACA or TXA), has a better
      anti-inflammatory profile when used in a similar setting for patients undergoing pediatric
      cardiothoracic surgery.

      Specific Aims:

      Evaluate whether TXA or EACA can decrease inflammatory response produced during redo
      sternotomy procedures in pediatric patients and which drug decreases the injury and/or
      cardiac dysfunction more as reflected by fluid balances, inotropic support, diuretic
      requirement, length of ventilator support, length of ICU stay, and length of hospital stay.
    

Intervention name(s): Tranexamic acid; Epsilon Aminocaproic Acid
Intervention type(s): Drug; Drug
Intervention description(s): TXA Loading dose: 31 mg/kg diluted to 2 ml/kg NS (in syringe)
31 x _______kg = _______ mg TXA (max: 930mg)
2 x _______ kg = _______ ml NS (max: 60 ml)
TXA infusion: 14 mg/kg hour = 1 ml/kg/hour (6 hour bag) (Max rate of infusion = 30ml/hr)
14 x ______ kg = _____mg x 6 = ______ mg TXA (max: 2,520mg)
1 x ______ kg = _______ml x 6 = ______ ml NS (max: 180ml)
TXA second bolus in 1 ml/kg NS
< 16 kg: TXA 45 mg in 1 ml/kg NS = _______ml NS
16-30 kg: TXA 90 mg in 1 ml/kg NS = _______ml NS
> 30 kg: TXA 120 mg 1 ml/kg NS = _______ml NS (max 30ml); Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS
75 x _______kg = _______ mg EACA (max: 2,250mg)
2x _______ kg = _______ ml NS (max 60ml)
Aminocaproic acid infusion: 75 mg/kg hour = 1 ml/kg/hour (6 hour bag)
75 x ______ kg = _____mg x 6 = ______ mg EACA (max: 13,500 mg)
1 x ______ kg = _______ml x 6 = ______ ml NS (max: 180ml)
Aminocaproic acid second bolus: 75 mg/kg in 1ml/kg NS
75 x _______kg = _______ mg EACA (max: 2,250mg)
1 x _______ kg = _______ ml NS (max 30 ml)
Other intervention name(s): TXA; EACA
Intervention MeSH terms: Tranexamic Acid; Aminocaproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pediatric Cardiac surgery; Inflammatory response; Tranexamic acid; Epsilon Aminocaproic Acid