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The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scheduled fresh frozen plasma | Experimental | Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. |
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| Control | Active Comparator | Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh frozen plasma | Biological | Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. |
| Measure | Description | Time Frame |
|---|---|---|
| ECMO Pump Longevity | The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours | ECMO course (median 198 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic and Thrombotic Complications | Complications associated with coagulation in both the patient and the pump will be collected. | ECMO course (median 198 hours) |
| Antithrombin Levels | Compared antithrombin levels in neonates in control versus treatment group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center PICU and PCICU | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Scheduled Fresh Frozen Plasma | Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement. |
| FG001 | Control | Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Scheduled Fresh Frozen Plasma | Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. |
| 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, Categorical | Count of Participants |
| 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 | ECMO Pump Longevity | The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours | Posted | Median | Inter-Quartile Range | hours | ECMO course (median 198 hours) |
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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 | Scheduled Fresh Frozen Plasma | Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, or volume replacement. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial hemorrhage | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caroline Ozment | Duke University Hospital | 919-681-2554 |
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| ECMO course (median 198 hours) |
| Plasma Free Hemoglobin | Compare plasma free hemoglobin levels between control and treatment group | ECMO course (median 198 hours) |
| Red Blood Cell Transfusion | Compared red blood cell transfusion during ECMO for control versus treatment group | ECMO course (median 198 hours) |
| Time to Therapeutic aPTT | Compared time in hours to goal aPTT for control versus treatment group | ECMO course (median 198 hours) |
| Platelets Transfusion Requirement | Compared platelet transfusion during ECMO for control versus treatment group | ECMO course (median 198 hours) |
| Fresh Frozen Plasma Transfusion Requirements | Compared fresh frozen plasma transfusion during ECMO for control versus treatment group | ECMO course (median 198 hours) |
| BG001 | Control | Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Control | Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. |
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| Secondary | Hemorrhagic and Thrombotic Complications | Complications associated with coagulation in both the patient and the pump will be collected. | Posted | Number | participants | ECMO course (median 198 hours) |
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| Secondary | Antithrombin Levels | Compared antithrombin levels in neonates in control versus treatment group | Posted | Median | Inter-Quartile Range | percentage of antithrombin | ECMO course (median 198 hours) |
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| Secondary | Plasma Free Hemoglobin | Compare plasma free hemoglobin levels between control and treatment group | Posted | Median | Inter-Quartile Range | mg/dL | ECMO course (median 198 hours) |
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| Secondary | Red Blood Cell Transfusion | Compared red blood cell transfusion during ECMO for control versus treatment group | Posted | Median | Inter-Quartile Range | ml/kilogram/ECMO day | ECMO course (median 198 hours) |
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| Secondary | Time to Therapeutic aPTT | Compared time in hours to goal aPTT for control versus treatment group | Posted | Median | Inter-Quartile Range | hours | ECMO course (median 198 hours) |
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| Secondary | Platelets Transfusion Requirement | Compared platelet transfusion during ECMO for control versus treatment group | Posted | Median | Inter-Quartile Range | ml/kilogram/ECMO day | ECMO course (median 198 hours) |
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| Secondary | Fresh Frozen Plasma Transfusion Requirements | Compared fresh frozen plasma transfusion during ECMO for control versus treatment group | Posted | Median | Inter-Quartile Range | ml/kilogram/ECMO day | ECMO course (median 198 hours) |
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| 6 |
| 15 |
| 5 |
| 15 |
| 0 |
| 15 |
| EG001 | Control | Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. Fresh frozen plasma: Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. | 8 | 16 | 1 | 16 | 0 | 16 |
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| Gastrointestinal hemrrohage |
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| Stroke |
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Surgical bleed |
| Superiority |
| Fisher Exact | 0.5 | Gastrointestinal hemorrhage | Superiority |