---
title: Thrombopoietin Levels and Platelet Transfusion in Neonates
nct_id: NCT00549484
overall_status: COMPLETED
sponsor: Christiana Care Health Services
study_type: OBSERVATIONAL
primary_condition: Thrombocytopenia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00549484.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00549484"
ct_last_update_post_date: 2008-01-18
last_seen_at: "2026-05-12T06:42:01.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Thrombopoietin Levels and Platelet Transfusion in Neonates

**Official Title:** Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

**NCT ID:** [NCT00549484](https://clinicaltrials.gov/study/NCT00549484)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Christiana Care Health Services
- **Conditions:** Thrombocytopenia
- **Start Date:** 2003-05
- **Completion Date:** 2004-09
- **CT.gov Last Update:** 2008-01-18

## 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.

## 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.

## Eligibility

- **Maximum age:** 6 Months
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Preterm infants with thrombocytopenia
* Decision made by medical team to transfuse with platelets

Exclusion Criteria:

* Infants with major congenital malformations
```

## Arms

- **1** — 10 mL/kg platelet transfusion
- **2** — 15 mL / kg platelet transfusion

## Primary Outcomes

- **Reduction in TPO levels following platelet transfusion** _(time frame: Within 36 hours of transfusion)_

## Secondary Outcomes

- **Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.** _(time frame: Within 36 hours after platelet transfusion)_

## Locations (1)

- Christiana Hospital, Newark, Delaware, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.christiana hospital|newark|delaware|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00549484.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00549484*  
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