NCT05958511

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 15, 2023

Last Update Submit

July 15, 2023

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (3)

  • Identify the prevalence thrombocytopenia.

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

    Baseline

  • 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

  • Identify the outcome of thrombocytopenia

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

    Baseline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

130 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.

You may qualify if:

  • 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.

You may not qualify if:

  • patients older than 18 years
  • Patients diagnosed with congenital thrombocytopenia (TAR syndrome...etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2023

First Posted

July 24, 2023

Study Start

September 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07