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Phase 4 N=46 Randomized Other

Platelet Transfusion During Neonatal Open Heart Surgery

Cardiac Disease · Cardiac Surgery · Cardiopulmonary Bypass · Platelet Transfusion · Arrythmia, Cardiac

Enrolled (actual)
46
Serious AEs
9.5%
Results posted
Mar 2023
Primary outcome: Primary: Amount of Blood Products Transfused — 58; 103 milliliter per kilogram (mL/kg)

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Platelet Transfusion (Biological); FFP and Cryoprecipitate (Biological); PRBC and cell saver Transfusion (Biological); Factor Concentrate (Bebulin) (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
The University of Texas Health Science Center, Houston
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Amount of Blood Products Transfused
58; 103
SECONDARY
Number of Exposures of 4-PCC and Factor 7
5; 6
SECONDARY
Time From End of CPB to Sternal Closure (Chest Approximation)
1.48; 1.95
SECONDARY
Chest Tube Output
20; 23
SECONDARY
Inotropic Support at the Time of Entry to the Pediatric Intensive Care Unit (PICU) as Indicated by Inotrope Score
7.1; 5.6
SECONDARY
Length of Mechanical Ventilation
4.1; 8
SECONDARY
Number of Participants With Mortality at 30 Days
0; 0
SECONDARY
Number of Participants With Cardiopulmonary Resuscitation (CPR) Events
0; 4
SECONDARY
Number of Participants With Arrhythmia
3; 6

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

  • Redo open heart surgery
  • Bleeding Disorders - such as von Willebrand Disease, Hemophilia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03045068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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