Study of the Effect of Differing Platelet Transfusion Times in Neonates

Thrombocytopenia Clinical Trial

Official title:

The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948792
• Other study ID #: 14626
• Status: Completed
• Phase: N/A
• First received: July 27, 2009
• Last updated: June 13, 2011
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

Intervention

Procedure:
• Short platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes
• Long platelet transfusion
15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.

Locations

Country	Name	City	State
United States	Children's Hospital of Oklahoma	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View Citation

Murray NA, Roberts IA. Neonatal transfusion practice. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F101-7. Review. — View Citation

Roberts I, Murray NA. Neonatal thrombocytopenia: causes and management. Arch Dis Child Fetal Neonatal Ed. 2003 Sep;88(5):F359-64. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline-30 minutes after transfusion	No
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.	Baseline - 6 hours after transfusion	No
Primary	30 Minute-6 Hour Difference in Platelet Counts		30 minutes - 6 hours after transfusion	No