Trial Outcomes & Findings for Platelet Transfusion During Neonatal Open Heart Surgery (NCT NCT03045068)
NCT ID: NCT03045068
Last Updated: 2023-03-08
Results Overview
All Blood products administered (PRBC, FFP, Cryo, Platelets) from termination of CPB to first 24 hours post op
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
0-72 hours
Results posted on
2023-03-08
Participant Flow
Participant milestones
| Measure |
Study Group
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
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.
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
Received Intervention
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This data was not collected.
Baseline characteristics by cohort
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.1 Days
STANDARD_DEVIATION 3 • n=21 Participants
|
9.3 Days
STANDARD_DEVIATION 7 • n=21 Participants
|
8.7 Days
STANDARD_DEVIATION 5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
This data was not collected.
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
This data was not collected.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
21 participants
n=21 Participants
|
42 participants
n=42 Participants
|
|
Weight
Weight at birth
|
3.1 kilograms
STANDARD_DEVIATION 0.4 • n=21 Participants
|
3.0 kilograms
STANDARD_DEVIATION 0.5 • n=21 Participants
|
3.05 kilograms
STANDARD_DEVIATION 0.45 • n=42 Participants
|
|
Weight
Weight at surgery
|
3.1 kilograms
STANDARD_DEVIATION 0.4 • n=21 Participants
|
3.1 kilograms
STANDARD_DEVIATION 0.5 • n=21 Participants
|
3.1 kilograms
STANDARD_DEVIATION 0.45 • n=42 Participants
|
|
Number of participants with presence of genetic syndrome
|
4 participants
n=21 Participants
|
4 participants
n=21 Participants
|
8 participants
n=42 Participants
|
|
Number of participants with baseline oxygen saturation < 90%
|
10 Participants
n=21 Participants
|
11 Participants
n=21 Participants
|
21 Participants
n=42 Participants
|
|
The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score
Number of participants with STAT score of 2
|
1 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=42 Participants
|
|
The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score
Number of participants with STAT score of 3
|
4 Participants
n=21 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=42 Participants
|
|
The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score
Number of participants with STAT score of 4
|
11 Participants
n=21 Participants
|
9 Participants
n=21 Participants
|
20 Participants
n=42 Participants
|
|
The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score
Number of participants with STAT score of 5
|
5 Participants
n=21 Participants
|
8 Participants
n=21 Participants
|
13 Participants
n=42 Participants
|
|
Platelet count, pre-cardiopulmonary bypass (CPB)
|
288 K/cmm
STANDARD_DEVIATION 87 • n=21 Participants
|
246 K/cmm
STANDARD_DEVIATION 106 • n=21 Participants
|
267 K/cmm
STANDARD_DEVIATION 96.5 • n=42 Participants
|
|
Fibrinogen, pre-cardiopulmonary bypass (CPB)
|
267 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 75 • n=21 Participants
|
248 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 50 • n=21 Participants
|
257.5 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 62.5 • n=42 Participants
|
|
Maximal amplitude on kaolin-heparinase thromboelastography (MA [TEG]), pre-CPB
|
65 millimeter (mm)
STANDARD_DEVIATION 7 • n=21 Participants
|
63 millimeter (mm)
STANDARD_DEVIATION 7 • n=21 Participants
|
64 millimeter (mm)
STANDARD_DEVIATION 7 • n=42 Participants
|
PRIMARY outcome
Timeframe: 0-72 hoursAll Blood products administered (PRBC, FFP, Cryo, Platelets) from termination of CPB to first 24 hours post op
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Amount of Blood Products Transfused
|
58 milliliter per kilogram (mL/kg)
Standard Deviation 29
|
103 milliliter per kilogram (mL/kg)
Standard Deviation 80
|
SECONDARY outcome
Timeframe: 0-72 hoursNumber of exposures of 4-PCC and Factor 7
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Number of Exposures of 4-PCC and Factor 7
|
5 exposures
|
6 exposures
|
SECONDARY outcome
Timeframe: 0-72 hoursThis outcome reports the time from the end of the cardiopulmonary bypass (CPB) procedure to the time the sternum is closed.
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Time From End of CPB to Sternal Closure (Chest Approximation)
|
1.48 days
Standard Deviation 0.98
|
1.95 days
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 0-24 hoursA 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.
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Chest Tube Output
|
20 milliliter per kilogram (mL/kg)
Standard Deviation 11
|
23 milliliter per kilogram (mL/kg)
Standard Deviation 18
|
SECONDARY outcome
Timeframe: At the time of entry to the pediatric intensive care unit (PICU)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.
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Inotropic Support at the Time of Entry to the Pediatric Intensive Care Unit (PICU) as Indicated by Inotrope Score
|
7.1 score on a scale
Standard Deviation 3.7
|
5.6 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: from start of mechanical ventilation to end of mechanical ventilation (about 4-8 days)Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Length of Mechanical Ventilation
|
4.1 days
Standard Deviation 1.8
|
8 days
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 0-30 days30 day mortality
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Number of Participants With Mortality at 30 Days
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-72 hoursPerioperative cardiac arrest first 72 hours
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Number of Participants With Cardiopulmonary Resuscitation (CPR) Events
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0-72 hoursArrhythmia
Outcome measures
| Measure |
Study Group
n=21 Participants
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 Participants
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.
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
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
|
|---|---|---|
|
Number of Participants With Arrhythmia
|
3 Participants
|
6 Participants
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Group
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group
n=21 participants at risk
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 participants at risk
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.
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
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
|
|---|---|---|
|
General disorders
Cardiopulmonary Resuscitation (CPR) Event
|
0.00%
0/21 • 30 days
|
19.0%
4/21 • Number of events 4 • 30 days
|
Other adverse events
| Measure |
Study Group
n=21 participants at risk
Platelet Transfusion Management
1. 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)
2. 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.
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
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
|
Control Group
n=21 participants at risk
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.
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
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
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
14.3%
3/21 • Number of events 3 • 30 days
|
28.6%
6/21 • Number of events 6 • 30 days
|
Additional Information
Nischal K Gautam, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place