Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Sweden / NCT04598750
Recruiting Observational

The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

NCT04598750 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Observational
Started
2021-06-15
Last updated
2024-10-09

Condition(s) studied

Neonatal ThrombocytopeniaBleeding

Study 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

Sex
ALL
Min age
1 Day
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • NeoBAT score — 24 hours
    NeoBAT scores will include any bleeding since the last platelet count or over the prior 24 hours, whichever is shortest. This will serve to correlate bleeding scores (NeoBAT) with platelet counts, IPF% and IPC, PFA-100/200 CT-ADP, and to quantify changes in response to platelet transfusions. The scale is 1 to 4 with 1 being Minor Hemorrhage and 4 being Severe Hemorrhage.

Trial sites (8)

FacilityCityRegionStatus
Boston Children's Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Not Yet Recruiting
Intermountain Medical Center Murray Utah Not Yet Recruiting
Utah Valley Hospital Provo Utah Not Yet Recruiting
Amsterdam University Medical Centre Amsterdam Netherlands Not Yet Recruiting
Leiden University Medical Center Leiden Netherlands Not Yet Recruiting
Karolinska University Hospital Huddinge campus Huddinge Sweden Recruiting
Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital Stockholm Sweden Recruiting

More Karolinska Institutet trials in Sweden

Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study Active, not recruiting
Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers Starting soon
Single Nuclei Sequencing in Human Skeletal Muscle After Unloading Enrolling by invitation
Validation of a Novel Smartphone-based Method for Heart Rhythm Monitoring in the Home Environment Active, not recruiting
Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04598750 on ClinicalTrials.gov ↗ ← All trials in Sweden