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Difficulty recruiting and enrolling subjects.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pathogen-reduced (PR) platelet transfusions | Active Comparator | FDA approved and already used in this patient population |
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| Large volume delayed sampling - LVDS | Active Comparator | FDA approved and already used in this patient population |
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| No platelet transfusion | No Intervention | Subject will not receive a platelet transfusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Transfusion | Biological | All platelet transfusions will be given as 10mL/kg as is considered standard of care. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within the first 24 hours post-op. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During hospitalization in the first 48 hours (no follow-up visits necessary) |
| Total Platelet Volume Transfused in the First 48 Hours Post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Nellis, MD, MS | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morgan Stanley Children's Hospital at Columbia University | New York | New York | 10032 | United States | ||
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Large Volume Delayed Sampling - LVDS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Dec 31, 2023 |
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Total platelet 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 plasma 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. | Total cryoprecipitate volume transfused in the first 48 hours post-op. | During hospitalization in the first 48 hours (no follow-up visits necessary) |
| Komansky Children's Hospital at Weill Cornell |
| New York |
| New York |
| 10065 |
| United States |
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. |
| FG002 | No Platelet Transfusion | Subject will not receive a platelet transfusion |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | No Platelet Transfusion | Subject will not receive a platelet transfusion |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | in months (of note if patient's age is less than one month, it is noted as 0) | Median | Inter-Quartile Range | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | mL/kg | Within the first 24 hours post-op. |
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| 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) | Posted | Median | Inter-Quartile Range | mL/kg | During hospitalization in the first 48 hours (no follow-up visits necessary) |
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| Secondary | Total Platelet Volume Transfused in the First 48 Hours Post-op | Total platelet volume transfused in the first 48 hours post-op | This Outcome Measure was not assessed in the No Platelet Transfusion Arm/Group | Posted | Median | Inter-Quartile Range | mL/kg | During hospitalization in the first 48 hours (no follow-up visits necessary) |
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| Secondary | Total Plasma Volume Transfused in the First 48 Hours Post-op | Total plasma volume transfused in the first 48 hours post-op | This Outcome Measure was not assessed in the No Platelet Transfusion Arm/Group | Posted | Median | Inter-Quartile Range | mL/kg | During hospitalization in the first 48 hours (no follow-up visits necessary) |
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| Secondary | Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op. | Total cryoprecipitate volume transfused in the first 48 hours post-op. | This Outcome Measure was not assessed in the No Platelet Transfusion Arm/Group | Posted | Median | Inter-Quartile Range | mL/kg | During hospitalization in the first 48 hours (no follow-up visits necessary) |
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Adverse events data were collected during the subjects hospital course (varied by patient but no longer than 14 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | No Platelet Transfusion | Subject will not receive a platelet transfusion | 0 | 7 | 0 | 7 | 0 | 7 |
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Due to difficulty in recruiting and enrolling subjects, only descriptive statistics were used to describe the 9 enrolled subjects.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Nellis, MD | Weill Cornell Medicine | 2127463056 | man9026@med.cornell.edu |
| Jun 17, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017713 | Platelet Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| White |
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| Other |
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| Participants |
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| Participants |
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| Participants |
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