The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study

NCT02371330 | Completed

• 1 other identifier: TRF-1516
• Study Type: observational
• Target: 76
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates \<32 weeks gestational age or with a birth weight \<1500 grams and with different degrees of thrombocytopenia. The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. A bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.

Conditions

Thrombocytopenia

Keywords

Thrombocytopenia; Neonate; PFA-100; Neo-BAT; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)

  The NeoBAT is a simple, reliable and objective tool for the standardized assessment of bleeding in neonates, which was developed by an international team of experts based on the World Health Organization bleeding score for adults.

  study period: 5 days

Secondary Outcomes (1)

• Number of thrombotic events

  up to post-conceptional age 36 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the Neonatal Intensive Care Unit who are \<32 weeks gestation or with a birth weight \<1500 grams.

You may qualify if:

• \<32 weeks gestation or with a birth weight \<1500 grams;
• Have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count \<100x109/L;
• Have a parent/guardian willing to comply with the protocol and provide written informed consent.

You may not qualify if:

• Are not expected to survive by the Attending Neonatologist;
• Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology);
• Have a major chromosomal anomaly such as Trisomy 13, 18, or 21.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Thrasher Research Fund: collaborator

Study Sites (2)

Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System

Charlotte, North Carolina, 28203, United States

Location

Astrid Lindgren Children's Hospital, Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Related Publications (1)

• Deschmann E, Sola-Visner M, Saxonhouse MA. Primary hemostasis in neonates with thrombocytopenia. J Pediatr. 2014 Jan;164(1):167-72. doi: 10.1016/j.jpeds.2013.08.037. Epub 2013 Oct 3.

  PMID: 24094764 BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia; Hemorrhage

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emoke Deschmann, M.D., M.M.Sc.

  Department of Women's and Children's Health, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.M.Sc., Attending Neonatologist

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 25, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

SE (1); US (1)