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To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long transfusion group | Active Comparator | This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours. |
|
| Short transfusion group | Experimental | This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short platelet transfusion | Procedure | 15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post-transfusion Platelet Counts | The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion. | Baseline-30 minutes after transfusion |
| Change in Post-transfusion Platelet Counts | The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion. | Baseline - 6 hours after transfusion |
| 30 Minute-6 Hour Difference in Platelet Counts | 30 minutes - 6 hours after transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Dannaway, M.D. | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12823341 | Background | British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of platelet transfusions. Br J Haematol. 2003 Jul;122(1):10-23. doi: 10.1046/j.1365-2141.2003.04468.x. No abstract available. | |
| 19117893 | Background | Josephson CD, Su LL, Christensen RD, Hillyer CD, Castillejo MI, Emory MR, Lin Y, Hume H, Easley K, Poterjoy B, Sola-Visner M. Platelet transfusion practices among neonatologists in the United States and Canada: results of a survey. Pediatrics. 2009 Jan;123(1):278-85. doi: 10.1542/peds.2007-2850. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short and Long Transfusion Group | This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Short and Long Transfusion Group | This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Post-transfusion Platelet Counts | The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion. | Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy. | Posted | Median | Full Range | Platelets (*10^3/mm^3) | Baseline-30 minutes after transfusion | transfusions | Participants |
|
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Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.
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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 | Long Transfusion Group | This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Dannaway | University of Oklahoma Health Sciences Center | 4052715215 | 42048 | douglas-dannaway@ouhsc.edu |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| Long platelet transfusion | Procedure | 15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours. |
|
| 14977890 | Background | Murray NA, Roberts IA. Neonatal transfusion practice. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F101-7. doi: 10.1136/adc.2002.019760. |
| 12937037 | Background | Roberts I, Murray NA. Neonatal thrombocytopenia: causes and management. Arch Dis Child Fetal Neonatal Ed. 2003 Sep;88(5):F359-64. doi: 10.1136/fn.88.5.f359. |
| 18684573 | Background | Sola-Visner M, Saxonhouse MA, Brown RE. Neonatal thrombocytopenia: what we do and don't know. Early Hum Dev. 2008 Aug;84(8):499-506. doi: 10.1016/j.earlhumdev.2008.06.004. Epub 2008 Aug 5. |
| 18194380 | Background | Strauss RG. How I transfuse red blood cells and platelets to infants with the anemia and thrombocytopenia of prematurity. Transfusion. 2008 Feb;48(2):209-17. doi: 10.1111/j.1537-2995.2007.01592.x. Epub 2008 Jan 7. |
| Participants |
|
| Age Continuous | Median | Full Range | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Short Transfusion Group |
This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes. |
|
|
|
| Primary | Change in Post-transfusion Platelet Counts | The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion. | Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy. | Posted | Median | Full Range | Platelets (*10^3/mm^3) | Baseline - 6 hours after transfusion | Transfusions | Participants |
|
|
|
|
| Primary | 30 Minute-6 Hour Difference in Platelet Counts | Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy. | Posted | Median | Full Range | Platelets (*10^3/mm^3) | 30 minutes - 6 hours after transfusion | Transfusions | Participants |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Short Transfusion Group | This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes. | 0 | 15 | 0 | 15 |
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