Platelet Transfusion During Neonatal Open Heart Surgery | NCT03045068

Status Module

Description Module

Brief 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

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
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.

Detailed Description

What do we do at our institution? The vast majority of centers including ours continue to utilize a regimen for neonatal CPB prime that constitutes of PRBCs ( 20-30 ml/kg) added to achieve a hematocrit > 25 on CPB and FFP (20-30 ml/kg) to assist the lower antithrombin levels, improve heparin efficiency and improved suppression of the thrombin generation on CPB. Platelets are not added in the CPB prime at our institution. This regimen of avoiding donor apheresis platelets transfusion during early CPB is because of the known effects of CPB on native platelets resulting in decreases in count from hemodilution and mechanical damage. Donor apheresis platelets administered as an initial constituent of CPB prime also carry the risk of platelet activation during hypothermia and CPB with potential activation of the coagulation cascade. Fresh whole blood is also not used secondary to the difficulty and logistics pertaining to availability fresh whole blood makes this approach unattractive.

What is the advantage of adding platelet apheresis just prior to separation from CPB? We know that native platelets are significantly reduced in count and function with increasing duration of CPB and function diminishes independently of platelet count with hypothermia.11 The advantages of adding donor apheresis platelets just prior to separating from CPB are that the donor platelets don't get spalliated and deformed by the roller pumps for long durations, they are not subjected to the intense cooling and rewarming process and spared of the early reperfusion injury/inflammation. Furthermore, addition of 10 ml/kg of platelets would raise the platelet counts by at least 50% based on a previous study at this institution (IRB# HSC-MS-13-0647; post-CPB platelet transfusion of 28 ± 16 ml/kg resulted in elevation of platelet counts from 76 ± 27 to 223 ± 60 (109/L).

Effect of modified ultrafiltration (MUF): MUF is routinely performed immediately on termination of CPB and prior to protamine administration. During this stage, after successful weaning from CPB, 10-15% of the cardiac output from the arterial cannula along with residual volume from the venous reservoir of the CPB pump is pumped through a hemofilter placed under vacuum to allow rapid hemofiltration with the effluent returned via a single atrial venous cannula to the patient. This 15-minute rapid hemofiltration allows for removal of excess water, improvement in hematocrit with improved oxygen delivery, faster achievement of steady state inotrope levels with improved hemodynamics and removal of inflammatory mediators.12-14 While MUF improves hematocrit, it does not increase platelet count significantly, MUF has no effect on native platelet function.3 The biggest advantage of transfusion of apheresis platelets prior to termination of bypass versus standard practice of their transfusion after protamine is that the transfused fluid load of 10-15 ml/kg of platelets volume that would have diluted the red cell fraction (hematocrit) and impacted oxygen delivery and pulmonary dysfunction would now take the full benefit of modified ultrafiltration with excess fluid removal even prior to protamine administration with overall improved hemodynamics.

Institutional Blood transfusion Management for Neonatal CPB For the CPB prime: PRBCs (50ml/kg) are added to allow for a hematocrit >30 for the estimated blood volumes. FFP is added to the pump prime for all patients weighing less than 5 kilograms and in those who demonstrate heparin resistance on initial heparin dose response assays. Heparin is added in the CPB prime. Other constituents of the CPB prime are epsilon aminocaproic acid (50 mg/kg), cefazolin (30 mg/kg) and methylprednisolone.

Post CPB: Current practice in neonates is to administer a combination of cryoprecipitate, platelet and PRBC in a 1:1:1 ratio till hemostasis is achieved. 3PCC factor administration is based on diffuse clinical bleeding suggestive of coagulopathy that persists despite one round of cryoprecipitate and platelet transfusion.

Study Method:

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. Primary outcomes and secondary outcomes are detailed below.

Study Group Platelet Transfusion Management

Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology)
Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.

FFP and Cryoprecipitate:

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

PRBC and cell saver Transfusion:

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

3- Factor Concentrate (Bebulin):

Based on clinical bleeding and achievement of hemostasis

Control Group Platelet Transfusion Management 1. Pre-Termination of CPB- No intervention 2. 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

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
PRBC and cell saver Transfusion:

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

3 Factor Concentrate (Bebulin):
1. Based on clinical bleeding and achievement of hemostasis
  
  Objectives
  
  a) Volume of Blood Transfusion (PRBC, FFP, Cryo, Platelets) Number of Donor Exposures (PRBC, FFP, Cryo, Platelets) from termination of CPB to first 24 hours post op b) Number of exposures of 4-PCC and Factor 7 c) Time from termination of CPB to Chest Approximation
  1. Chest tube output first 24 hours
  2. Inotropic support at time of chest approximation and at 24 hours postop
  3. Length of mechanical ventilation
  4. 30 day mortality
  5. Mediastinal exploration
  6. Delayed sternal closure
  7. Perioperative cardiac arrest first 72 hours
  8. Arrhythmia
  Sample size- Based on pilot data we have collected in the standard procedure group, the mean and standard deviation (SD) of total blood product intake during first 24 hours is 125.3+/- 71.1 (ml/kg). To detect a 1*SD unit reduction on the total blood intake, we need 17 patients per group with 80% power at 0.05 significance level. To account for 20% drop out rate, we need 22 patients per group, i.e. 44 patients in total.
  
  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
  
  Screening and Recruitment:
  
  The list of newborns to be operated will be obtained daily from the operating room log.
  
  Care4 records and OR Tracking will be used to screen for patients Initials of Patients, Date of Brith, Date of Surgery and MRN will be collected. The Research Team ( PI and Co-PI) will make contact with the family member while obtaining the surgical and or the anesthesia consent.
  
  Data Collected ( routine Standard operating procedure data)
  
  Patient Demographics:
  
  MRN, Gestational age, Age at operation, weight at birth, weight at operation, primary Diagnosis, Other diagnosis,
  
  Operative Data:
  
  CPB time, Aortic Cross Clamp time, Deep Hypothermic Circulatory Arrest time, Antegrade Cerebral perfusion time, Case duration.
  
  Pump Prime Constituents:
  
  Inotrope score: at chest approximation {dopamine + dobutamine + (epinephrine*100) + (milrinone*10) 15 Procedure performed. Complications All Laboratory values performed from baseline to 24 hours postoperative
  
  a) Baseline- CBC with Platelets, Fibrinogen, TEG b) Rewarming, prior to termination at core temperature of 35*C- CBC with platelets, Fibrinogen, TEG c) Arrival to PICU- CBC with platelets, fibrinogen, TEG d) 24 hours post op- CBC with platelets, fibrinogen, TEG All Blood products administered with age of the blood product at time of administration (<5 days, > 5days) Post operative Length of Intubation STS reportable complications Mortality Cumulative fluid balance first 72 hours.
  
  Outcome Variables:
  
  d) Number of Donor Exposures (PRBC, FFP, Cryo, Platelets) from termination of CPB to first 24 hours post op e) Number of exposures of 4-PCC and Factor 7 f) Time from termination of CPB to Chest Approximation i) Chest tube output first 24 hours j) Inotropic support at time of chest approximation and at 24 hours postop k) Length of mechanical ventilation l) 30 day mortality m) Mediastinal exploration n) Delayed sternal closure o) Perioperative cardiac arrest first 72 hours p) Arrhythmia
  
  Study Risks:
  
  There are no perceivable risks from exposure to platelets since the patients will be exposed to platelet transfusion after protamine administration. Only the timing of administration is being changed in the study group.
  
  Informed Consent:
  
  A written informed consent will be obtained. If informed consent is not obtainable or refused, patients will be randomized to control arm.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.	Biological: Platelet Transfusion Biological: FFP and Cryoprecipitate Biological: PRBC and cell saver Transfusion Biological: Factor Concentrate (Bebulin)
Control Group	Active Comparator	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.	Biological: Platelet Transfusion Biological: FFP and Cryoprecipitate Biological: PRBC and cell saver Transfusion Biological: Factor Concentrate (Bebulin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet Transfusion	Biological	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

Outcomes Module

Measure	Description	Time Frame
Amount of Blood Products Transfused	All Blood products administered (PRBC, FFP, Cryo, Platelets) from termination of CPB to first 24 hours post op	0-72 hours

Secondary Outcomes

Measure	Description	Time Frame
Number of Exposures of 4-PCC and Factor 7	Number of exposures of 4-PCC and Factor 7	0-72 hours
Time From End of CPB to Sternal Closure (Chest Approximation)	This outcome reports the time from the end of the cardiopulmonary bypass (CPB) procedure to the time the sternum is closed.

Eligibility Module

Name	Affiliation	Role
Nischal K Gautam, MD	The University of Texas Health Science at Houston	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Hermann Hospital		Houston	Texas	77030	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 4, 2020

Arm/Group Information

ID	Title	Description
BG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
BG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00021 BG00121 BG00242

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Days

Title

Denominators

Categories

Title	Measurements
	OG00058± 29 OG001103± 80

Secondary

Number of Exposures of 4-PCC and Factor 7

Number of exposures of 4-PCC and Factor 7

Posted

Number

exposures

0-72 hours

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
OG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Secondary

Time From End of CPB to Sternal Closure (Chest Approximation)

This outcome reports the time from the end of the cardiopulmonary bypass (CPB) procedure to the time the sternum is closed.

Posted

Mean

Standard Deviation

days

0-72 hours

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
OG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Secondary

Chest Tube Output

A chest tube is a flexible tube used to drain fluid or air from the chest, and the amount removed over 24 hours will be reported.

Posted

Mean

Standard Deviation

milliliter per kilogram (mL/kg)

0-24 hours

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
OG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Secondary

Inotropic Support at the Time of Entry to the Pediatric Intensive Care Unit (PICU) as Indicated by Inotrope Score

The inotrope score equals [dopamine dose (mg/kg/min) + dobutamine dose (mg/kg/min) + epinephrine dose (mg/kg/min) X100 + milrinone (mg/kg/min) x 10]. A higher score indicates that the patient is in more critical condition and requires a greater level of treatment. The score ranges from 0 to about 90.

Posted

Mean

Standard Deviation

score on a scale

At the time of entry to the pediatric intensive care unit (PICU)

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Secondary

Length of Mechanical Ventilation

Posted

Mean

Standard Deviation

days

from start of mechanical ventilation to end of mechanical ventilation (about 4-8 days)

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
OG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Secondary

Number of Participants With Mortality at 30 Days

30 day mortality

Posted

Count of Participants

Participants

0-30 days

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
OG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Secondary

Number of Participants With Cardiopulmonary Resuscitation (CPR) Events

Perioperative cardiac arrest first 72 hours

Posted

Count of Participants

Participants

0-72 hours

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
OG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Secondary

Number of Participants With Arrhythmia

Arrhythmia

Posted

Count of Participants

Participants

0-72 hours

ID	Title	Description
OG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis
OG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Study Group	Platelet Transfusion Management Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology) Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis	0	21	0	21	3	21
EG001	Control Group	Platelet Transfusion Management Pre-Termination of CPB- No intervention Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion. Platelet Transfusion: 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 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 PRBC and cell saver Transfusion: 1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology Factor Concentrate (Bebulin): 1. Based on clinical bleeding and achievement of hemostasis	0	21	4	21	6	21

Ancestor Terms

ID	Term
D016913	Blood Component Transfusion
D001803	Blood Transfusion
D001691	Biological Therapy
D013812	Therapeutics
D001772	Blood Cell Count
D002452	Cell Count
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006403	Hematologic Tests
D010979	Platelet Function Tests
D008919	Investigative Techniques
D002468	Cell Physiological Phenomena
D001790	Blood Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena
D004792	Enzyme Precursors
D045762	Enzymes and Coenzymes
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011498	Protein Precursors
D001685	Biological Factors

ID	Term
D006331	Heart Diseases
D001145	Arrhythmias, Cardiac

ID	Term
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D017713	Platelet Transfusion
D010976	Platelet Count
D005164	Factor IX