Platelet Transfusion During Neonatal Open Heart Surgery

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.

Conditions

• Cardiac Disease
• Cardiac Surgery
• Cardiopulmonary Bypass
• Platelet Transfusion
• Arrythmia, Cardiac
• Mortality

Interventions

BIOLOGICAL

Platelet Transfusion

Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. 1. Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts 2. Subsequent platelet transfusion continued till completion via central venous access to the patient

BIOLOGICAL

FFP and Cryoprecipitate

1. 1 unit of cryoprecipitate administered during MUF and or after MUF as needed 2. FFP transfusion 10ml/kg during MUF and or after MUF as needed

BIOLOGICAL

PRBC and cell saver Transfusion

1\. Transfuse for target Hematocrit \> 40 in neonates with SV physiology; Transfuse for Hematocrit\> 33 for 2-Ventricle physiology

BIOLOGICAL

Factor Concentrate (Bebulin)

1\. Based on clinical bleeding and achievement of hemostasis

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Nischal K Gautam, MD · The University of Texas Health Science at Houston

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

3 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-11

Primary Completion

2018-10-01

Completion

2018-11-01

FDA Drug

Yes

Countries

• United States

Study Locations