Platelet Transfusion During Neonatal Open Heart Surgery
Condition: Cardiac Disease; Cardiac Surgery; Cardiopulmonary Bypass; Platelet Transfusion; Arrythmia, Cardiac; Mortality
MeSH terms: Arrhythmias, Cardiac; Heart Diseases
Intervention: Platelet Transfusion; FFP and Cryoprecipitate; PRBC and cell saver Transfusion; Factor Concentrate (Bebulin)
Intervention description: Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.
Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts
Subsequent platelet transfusion continued till completion via central venous access to the patient; 1 unit of cryoprecipitate administered during MUF and or after MUF as needed
FFP transfusion 10ml/kg during MUF and or after MUF as needed; 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology; 1. Based on clinical bleeding and achievement of hemostasis
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized trial in neonates comparing platelet apheresis transfusion prior to termination of CPB versus standard transfusion of platelet apheresis after modified ultrafiltration and protamine administration
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 1 Day
Maximum age: 3 Months
Healthy volunteers: No

Summary:

      Hypothesis:

      Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and
      administration of donor apheresis platelets just prior to termination of bypass will assist
      in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood
      products after cardiac surgery.

      Background:

      What is the Problem? - Bleeding, Transfusion and Outcomes

        1. Excessive bleeding after neonatal cardiac surgery has been independently associated with
           increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart
           surgery has multiple etiologies such as immaturity of the building blocks of
           coagulation, effects of deep hypothermia, longer CPB times, altered flow states and
           dilutional state induced by being on CPB leading to low platelet count, low platelet
           function, low fibrinogen levels, altered fibrinogen polymerization, complement
           activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass
           in children was deemed to be the CPB circuit volume and the effect of hemodilution.4

        2. The dilutional coagulopathy after neonatal CPB requires intense damage control
           resuscitation with massive transfusion of platelets, packed red blood cells (PRBC),
           cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a
           previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates
           undergoing open-heart surgery there was a significant drop in platelet counts after
           bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this
           drop , the average intraoperative transfusion load in neonates undergoing cardiac
           surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg,
           cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In
           addition 72% of these patients were exposed to a 3-factor prothrombin complex
           concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in
           achieving hemostasis, it comes with significant effects on post CPB hemodynamics,
           constantly changing hematocrit, variable blood volume with inability to achieve steady
           state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary
           hypertension.

      Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has
      distinct advantages of reducing transfusions and improving outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

        All neonates and infants less than 3 months of age under 4 kilograms undergoing open heart
        surgery and cardiopulmonary bypass

        Exclusion Criteria:

          1. Redo open heart surgery

          2. Bleeding Disorders - such as von Willebrand Disease, Hemophilia