Thrombocytopenia
Conditions
Keywords
platelets, transfusion, thrombocytopenia
Brief summary
To evaluate changes in platelet counts and hemodynamics between rapid and long platelet infusion groups.
Detailed description
1. It is our hypothesis that the change in post-transfusion platelet counts of babies who receive platelets over 30 minutes (short transfusion group) will be significantly different from the change in babies who receive platelets over two hours (long transfusion group) when platelets are checked immediately after transfusion and 6 hours after the completion of transfusion. 2. We also expect there to be significant differences in the platelet counts drawn thirty minutes after transfusion compared to the counts drawn 6 hours after the completion of the transfusion in either group.
Interventions
PROCEDUREShort platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes
PROCEDURELong platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Infants with significant thrombocytopenia requiring a transfusion of platelets.
Exclusion criteria
* Infants requiring extracorporeal membranous oxygenation. * Infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus). * Babies diagnosed with neonatal alloimmune thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-transfusion Platelet Counts | Baseline-30 minutes after transfusion | The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion. |
| 30 Minute-6 Hour Difference in Platelet Counts | 30 minutes - 6 hours after transfusion | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Short and Long Transfusion Group |
|---|---|
| Age, Categorical <=18 years | 21 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 26 Days FULL_RANGE 0.09 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 |
Outcome results
Primary
30 Minute-6 Hour Difference in Platelet Counts
Time frame: 30 minutes - 6 hours after transfusion
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long Transfusion Group | 30 Minute-6 Hour Difference in Platelet Counts | -17.5 Platelets (*10^3/mm^3) |
| Short Transfusion Group | 30 Minute-6 Hour Difference in Platelet Counts | -3 Platelets (*10^3/mm^3) |
Comparison: The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44.p-value: 0.09Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline - 6 hours after transfusion
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long Transfusion Group | Change in Post-transfusion Platelet Counts | 75 Platelets (*10^3/mm^3) |
| Short Transfusion Group | Change in Post-transfusion Platelet Counts | 104 Platelets (*10^3/mm^3) |
Comparison: The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44.p-value: 0.26Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline-30 minutes after transfusion
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long Transfusion Group | Change in Post-transfusion Platelet Counts | 99 Platelets (*10^3/mm^3) |
| Short Transfusion Group | Change in Post-transfusion Platelet Counts | 97.5 Platelets (*10^3/mm^3) |
Comparison: The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44.p-value: 0.8Wilcoxon (Mann-Whitney)