Clinical trial NCT00948792: Study of the Effect of Differing Platelet Transfusion Times in Neonates
Official title: The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombocytopenia
Keywords: platelets
transfusion
thrombocytopenia
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Post-transfusion Platelet Counts
timeFrame: Baseline-30 minutes after transfusion
measure: Change in Post-transfusion Platelet Counts
timeFrame: Baseline - 6 hours after transfusion
measure: 30 Minute-6 Hour Difference in Platelet Counts
timeFrame: 30 minutes - 6 hours after transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Children's Hospital of Oklahoma
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Douglas Dannaway, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.