NCT04598750 · Karolinska Institutet
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
(NEOHAT-2)
What this study is about
This is a forward-looking 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Boston, Massachusetts
- Murray, Utah
- Provo, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2024 · Source of record for eligibility and locations