Trial Outcomes & Findings for Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial (NCT NCT05293106)
NCT ID: NCT05293106
Last Updated: 2024-08-20
Results Overview
Chest tube output for first 24 hours following cardiopulmonary bypass surgery
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
Within the first 24 hours post-op.
Results posted on
2024-08-20
Participant Flow
Pediatric patients were recruited in the pre-operative cardiology clinic from 6/1/2022-12/31/2023 at Komansky Children's Hospital at Weill Cornell. For neonates admitted for their birth and awaiting cardiac surgery, the families were approached approached in the neonatal intensive care unit by the CT surgery team.
Participant milestones
| Measure |
Pathogen-reduced (PR) Platelet Transfusions
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
Large Volume Delayed Sampling - LVDS
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
No Platelet Transfusion
Subject will not receive a platelet transfusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
7
|
|
Overall Study
COMPLETED
|
1
|
1
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
Baseline characteristics by cohort
| Measure |
Pathogen-reduced (PR) Platelet Transfusions
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
Large Volume Delayed Sampling - LVDS
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
No Platelet Transfusion
n=7 Participants
Subject will not receive a platelet transfusion
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
0 months
n=5 Participants
|
72 months
n=7 Participants
|
117 months
n=5 Participants
|
81 months
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within the first 24 hours post-op.Chest tube output for first 24 hours following cardiopulmonary bypass surgery
Outcome measures
| Measure |
Pathogen-reduced (PR) Platelet Transfusions
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
Large Volume Delayed Sampling - LVDS
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
No Platelet Transfusion
n=7 Participants
Subject will not receive a platelet transfusion
|
|---|---|---|---|
|
Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
|
35.3 mL/kg
Interval 35.3 to 35.3
|
21.0 mL/kg
Interval 21.0 to 21.0
|
6.6 mL/kg
Interval 5.1 to 10.5
|
SECONDARY outcome
Timeframe: During hospitalization in the first 48 hours (no follow-up visits necessary)Total dose red blood cell volume transfused in first 48 hours post-op (includes both red blood cell as well as cellsaver)
Outcome measures
| Measure |
Pathogen-reduced (PR) Platelet Transfusions
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
Large Volume Delayed Sampling - LVDS
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
No Platelet Transfusion
n=7 Participants
Subject will not receive a platelet transfusion
|
|---|---|---|---|
|
Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op
|
18.8 mL/kg
Interval 18.8 to 18.8
|
20.3 mL/kg
Interval 20.3 to 20.3
|
4.8 mL/kg
Interval 0.0 to 6.3
|
SECONDARY outcome
Timeframe: During hospitalization in the first 48 hours (no follow-up visits necessary)Population: This Outcome Measure was not assessed in the No Platelet Transfusion Arm/Group
Total platelet volume transfused in the first 48 hours post-op
Outcome measures
| Measure |
Pathogen-reduced (PR) Platelet Transfusions
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
Large Volume Delayed Sampling - LVDS
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
No Platelet Transfusion
Subject will not receive a platelet transfusion
|
|---|---|---|---|
|
Total Platelet Volume Transfused in the First 48 Hours Post-op
|
18.8 mL/kg
Interval 18.8 to 18.8
|
14.1 mL/kg
Interval 14.1 to 14.1
|
—
|
SECONDARY outcome
Timeframe: During hospitalization in the first 48 hours (no follow-up visits necessary)Population: This Outcome Measure was not assessed in the No Platelet Transfusion Arm/Group
Total plasma volume transfused in the first 48 hours post-op
Outcome measures
| Measure |
Pathogen-reduced (PR) Platelet Transfusions
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
Large Volume Delayed Sampling - LVDS
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
No Platelet Transfusion
Subject will not receive a platelet transfusion
|
|---|---|---|---|
|
Total Plasma Volume Transfused in the First 48 Hours Post-op
|
18.1 mL/kg
Interval 18.1 to 18.1
|
10 mL/kg
Interval 10.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: During hospitalization in the first 48 hours (no follow-up visits necessary)Population: This Outcome Measure was not assessed in the No Platelet Transfusion Arm/Group
Total cryoprecipitate volume transfused in the first 48 hours post-op.
Outcome measures
| Measure |
Pathogen-reduced (PR) Platelet Transfusions
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
Large Volume Delayed Sampling - LVDS
n=1 Participants
FDA approved and already used in this patient population
Platelet Transfusion: All platelet transfusions will be given as 10mL/kg as is considered standard of care.
|
No Platelet Transfusion
Subject will not receive a platelet transfusion
|
|---|---|---|---|
|
Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.
|
17.5 mL/kg
Interval 17.5 to 17.5
|
5.1 mL/kg
Interval 5.1 to 5.1
|
—
|
Adverse Events
Pathogen-reduced (PR) Platelet Transfusions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Large Volume Delayed Sampling - LVDS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Platelet Transfusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place