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PFA100: The Impact of Platelet Functions on Spontaneous Ductal Closure in Preterm Infants

Sponsor
Ankara University (Other)
Overall Status
Completed
CT.gov ID
NCT02010879
Collaborator
(none)
80
Enrollment
1
Location
13
Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure. Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patent ductus arterioses is a common problem which involves both pulmonary and cardiac outcomes in preterm infants. Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure.

    The investigators aim to investigate the relation between thrombocytopenia and platelet functions in pathogenesis of spontaneous ductal closure. The investigators hypothesize that Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Impact of Platelet Count, Platelet Mass Index and Platelet Function Evaluated by Platelet Function Analyzer (PFA-100) on Spontaneous Ductal Closure in Preterm Infants
    Study Start Date :
    Dec 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Jan 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. spontaneous ductal closure [8 weeks]

      ductal closure confirmed by echocardiography on postnatal 2-3 days

    Secondary Outcome Measures

    1. need for treatment [8 weeks]

      any need for medical treatment (ibuprofen or paracetamol) or surgical treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Days to 7 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • gestational age lower than 30 weeks and birth weight lower than 1500 g

    • obtained informed consent

    Exclusion Criteria:

    • any received medical treatment in first 2 days of life

    • death in first 2 days

    • patients who received any thrombocyte or fresh frozen plasma suspensions

    • any known genetic thrombocyte disorder in the family

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara University Children's Hospital Ankara Turkey 06100

    Sponsors and Collaborators

    • Ankara University

    Investigators

    • Principal Investigator: Omer Erdeve, Professor, Ankara University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omer Erdeve, Associate Professor, Ankara University
    ClinicalTrials.gov Identifier:
    NCT02010879
    Other Study ID Numbers:
    • PDAPFA-100 TRIAL
    First Posted:
    Dec 13, 2013
    Last Update Posted:
    Apr 26, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Omer Erdeve, Associate Professor, Ankara University
    patent ductus arterioses
    ductal closure
    thrombocyte
    Additional relevant MeSH terms:
    Ductus Arteriosus, Patent

    Study Results

    No Results Posted as of Apr 26, 2016