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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05958511
Other study ID # Thrombocytopenia
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date December 1, 2024

Study information

Verified date July 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Identify the prevalence thrombocytopenia. The study is aimed to identify the prevalence of thrombocytopenia in patients admitted to pediatric intensive care unit. Baseline
Primary Identify the risk factors of thrombocytopenia The study is aimed to identify the risk factors of thrombocytopenia in patients admitted to pediatric intensive care unit. Baseline
Primary Identify the outcome of thrombocytopenia The study is aimed to identify the outcome of thrombocytopenia in patients admitted to pediatric intensive care unit. Baseline
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