Cardiopulmonary Bypass Surgery
Conditions
Keywords
Platelet Transfusion, LVDS platelet transfusion, PR platelet transfusion
Brief summary
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).
Detailed description
This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.
Interventions
BIOLOGICALPlatelet Transfusion
All platelet transfusions will be given as 10mL/kg as is considered standard of care.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 0 up to and including 18 years of age * Undergoing elective cardiopulmonary bypass surgery * Are planned to have a chest tube placed in the operating room prior to chest closure
Exclusion criteria
* \>/=19 years of age * Preterm infants (less than 38-week gestational age at time of surgery) * On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery * Family requests limitation of blood products (i.e. Jehovah's Witness) * Congenital bleeding disorder * Are planned to require ECMO post-op * Previously enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery | Within the first 24 hours post-op. | Chest tube output for first 24 hours following cardiopulmonary bypass surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op | 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) |
| Total Platelet Volume Transfused in the First 48 Hours Post-op | During hospitalization in the first 48 hours (no follow-up visits necessary) | Total platelet volume transfused in the first 48 hours post-op |
| Total Plasma Volume Transfused in the First 48 Hours Post-op | During hospitalization in the first 48 hours (no follow-up visits necessary) | Total plasma volume transfused in the first 48 hours post-op |
| Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op. | During hospitalization in the first 48 hours (no follow-up visits necessary) | Total cryoprecipitate volume transfused in the first 48 hours post-op. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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. | 1 |
| No Platelet Transfusion Subject will not receive a platelet transfusion | 7 |
| Total | 9 |
Baseline characteristics
| Characteristic | Pathogen-reduced (PR) Platelet Transfusions | Large Volume Delayed Sampling - LVDS | No Platelet Transfusion | Total |
|---|---|---|---|---|
| Age, Continuous | 0 months | 72 months | 117 months | 81 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 0 Participants | 4 Participants | 5 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 7 |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 7 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 7 |
Outcome results
Primary
Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
Chest tube output for first 24 hours following cardiopulmonary bypass surgery
Time frame: Within the first 24 hours post-op.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen-reduced (PR) Platelet Transfusions | Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery | 35.3 mL/kg |
| Large Volume Delayed Sampling - LVDS | Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery | 21.0 mL/kg |
| No Platelet Transfusion | Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery | 6.6 mL/kg |
Secondary
Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.
Total cryoprecipitate volume transfused in the first 48 hours post-op.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen-reduced (PR) Platelet Transfusions | Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op. | 17.5 mL/kg |
| Large Volume Delayed Sampling - LVDS | Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op. | 5.1 mL/kg |
Secondary
Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op
Total dose red blood cell volume transfused in first 48 hours post-op (includes both red blood cell as well as cellsaver)
Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen-reduced (PR) Platelet Transfusions | Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op | 18.8 mL/kg |
| Large Volume Delayed Sampling - LVDS | Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op | 20.3 mL/kg |
| No Platelet Transfusion | Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op | 4.8 mL/kg |
Secondary
Total Plasma Volume Transfused in the First 48 Hours Post-op
Total plasma volume transfused in the first 48 hours post-op
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen-reduced (PR) Platelet Transfusions | Total Plasma Volume Transfused in the First 48 Hours Post-op | 18.1 mL/kg |
| Large Volume Delayed Sampling - LVDS | Total Plasma Volume Transfused in the First 48 Hours Post-op | 10 mL/kg |
Secondary
Total Platelet Volume Transfused in the First 48 Hours Post-op
Total platelet volume transfused in the first 48 hours post-op
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen-reduced (PR) Platelet Transfusions | Total Platelet Volume Transfused in the First 48 Hours Post-op | 18.8 mL/kg |
| Large Volume Delayed Sampling - LVDS | Total Platelet Volume Transfused in the First 48 Hours Post-op | 14.1 mL/kg |