NCT04598750 The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
| NCT ID | NCT04598750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Neonatal Thrombocytopenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-06-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2021-06-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.
Eligibility Criteria
Inclusion Criteria: * Have a gestational age \<32 weeks and a birth weight ≥500 grams; * Have a platelet count \<100 x 109/L; and * Have a parent/guardian willing to provide written informed consent. Exclusion Criteria: * Are not expected to survive for \>24 hours by the Attending Neonatologist; * Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).
Contact & Investigator
Emöke Deschmann, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT04598750 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, studying Neonatal Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04598750 currently recruiting?
Yes, NCT04598750 is actively recruiting participants. Contact the research team at emoke.deschmann@regionstockholm.se for enrollment information.
Where is the NCT04598750 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Murray, United States, Provo, United States and 4 additional locations.
Who is sponsoring the NCT04598750 clinical trial?
NCT04598750 is sponsored by Karolinska Institutet. The principal investigator is Emöke Deschmann, MD, PhD at Karolinska Institutet. The trial plans to enroll 250 participants.