Thrombopoietin Levels and Platelet Transfusion in Neonates
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| First Received Date ICMJE | October 24, 2007 | ||||||||
| Last Updated Date | January 16, 2008 | ||||||||
| Start Date ICMJE | May 2003 | ||||||||
| Primary Completion Date | September 2004 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction in TPO levels following platelet transfusion [ Time Frame: Within 36 hours of transfusion ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Reduction in TPO levels following platelet transfusion | ||||||||
| Change History | Complete list of historical versions of study NCT00549484 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg. [ Time Frame: Within 36 hours after platelet transfusion ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg. | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Thrombopoietin Levels and Platelet Transfusion in Neonates | ||||||||
| Official Title ICMJE | Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia | ||||||||
| Brief Summary | Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production. |
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| Detailed Description | Thrombocytopenia, defined as a platelet count < 150,000/mm3, is a very common hematologic problem in the neonatal period. Multiple etiologies are known to be associated with thrombocytopenia in neonates. Thrombopoietin (TPO) is known to be the central regulator of megakaryocyte and platelet production in adults and infants. However, the role of TPO in neonatal platelet regulation is not well understood. TPO levels have been shown to be higher in neonates with thrombocytopenia, with a decrease in TPO after resolution of the thrombocytopenia. The response of TPO levels in neonates after platelet transfusion has never been studied. In addition, the optimal volume of platelet transfusions has never been studied in neonates. This study will evaluate the response to 2 different volumes of platelet transfusion. We hypothesize that a decrease in plasma TPO levels will be seen following a platelet transfusion in a population of neonates with thrombocytopenia. We also hypothesize that a platelet transfusion of 15 mL/kg will result in a greater rise in platelet count than a transfusion pf 10 mL/kg of platelets. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Blood samples were collected pre and post platelet transfusion. Samples included platelet count, thrombopoietin, and platelet factor 4. |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Infants who require platelet transfusion |
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| Condition ICMJE | Thrombocytopenia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | September 2004 | ||||||||
| Primary Completion Date | September 2004 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 6 Months | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00549484 | ||||||||
| Other Study ID Numbers ICMJE | CCC#23049 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | T. Alex Kline, Christiana Hospital | ||||||||
| Study Sponsor ICMJE | Christiana Care Health Services | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Christiana Care Health Services | ||||||||
| Verification Date | January 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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