Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05958511
Collaborator
(none)
130
15

Study Details

Study Description

Brief Summary

The many comorbidities in the severely ill patient also make thrombocytopenia very common (∼ 40%) in intensive care unit patients. The risk of bleeding is high with severe thrombocytopenia and is enhanced in intensive care patients with mild or moderately low platelet counts when additional factors are present that interfere with normal hemostatic mechanisms (eg, platelet function defects, hyperfibrinolysis, invasive procedures, or catheters).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The many comorbidities in the severely ill patient also make thrombocytopenia very common (∼ 40%) in intensive care unit patients. The risk of bleeding is high with severe thrombocytopenia and is enhanced in intensive care patients with mild or moderately low platelet counts when additional factors are present that interfere with normal hemostatic mechanisms (eg, platelet function defects, hyperfibrinolysis, invasive procedures, or catheters). Even if not associated with bleeding, low platelet counts often influence patient management and may prompt physicians to withhold or delay necessary invasive interventions, reduce the intensity of anticoagulation, order prophylactic platelet transfusion, or change anticoagulants due to fear of heparin-induced thrombocytopenia.

    The many comorbidities in the severely ill patient also affect platelet homeostasis, and, consequently, thrombocytopenia is very common in critically ill patients treated in the intensive care unit (ICU). Thrombocytopenia is usually defined as a platelet count of < 150 × 109/L, whereas severe thrombocytopenia is considered as platelet counts < 50 × 109/L. Thrombocytopenia has six major mechanisms, and it can be induced by hemodilution, increased platelet consumption (both are very common in the ICU after tissue trauma, bleeding, and disseminated intravascular coagulopathy [DIC]), increased platelet destruction (ie, immune mechanisms), decreased platelet production, increased platelet sequestration, or by the laboratory artefact of pseudothrombocytopenia .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    130 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Risk Factors and Outcome of Thrombocytopenia in Intensive Care Unit Patients in Assiut Pediatric University Hospital
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Identify the prevalence thrombocytopenia. [Baseline]

      The study is aimed to identify the prevalence of thrombocytopenia in patients admitted to pediatric intensive care unit.

    2. Identify the risk factors of thrombocytopenia [Baseline]

      The study is aimed to identify the risk factors of thrombocytopenia in patients admitted to pediatric intensive care unit.

    3. Identify the outcome of thrombocytopenia [Baseline]

      The study is aimed to identify the outcome of thrombocytopenia in patients admitted to pediatric intensive care unit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Children and infants aged one month to 18 years admitted to the ICU in period from August 2023 to August 2024 and developed thrombocytopenia documented in laboratory investigation done in PICU.
    Exclusion Criteria:
    • patients older than 18 years

    • Patients diagnosed with congenital thrombocytopenia (TAR syndrome...etc)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aya Metwli Hammam, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05958511
    Other Study ID Numbers:
    • Thrombocytopenia
    First Posted:
    Jul 24, 2023
    Last Update Posted:
    Jul 24, 2023
    Last Verified:
    Jul 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 24, 2023