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NCT04170231 Clinical Trial

Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses

Cancer Clinical Trial

Official title:
Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04170231
Other study ID # 19-407
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 18, 2019
Est. completion date October 18, 2023

Study information
Verified date October 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

"Bleeding in Critically Ill Children with Underlying Oncologic Diagnoses ," will be a prospective observational cohort study looking at the epidemiology of bleeding in the pediatric ICU population at MSK.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date October 18, 2023
Est. primary completion date October 18, 2023
Accepts healthy volunteers No
Gender All
Age group 28 Days to 18 Years
Eligibility Inclusion Criteria: - All children (=28 days old through 18 years of age) with an oncologic diagnosis admitted to the PICU at Memorial Sloan Kettering Cancer Center - An oncologic diagnosis will include those with a cancer diagnosis or those being treated at MSK for blood disorders, immunodeficiencies and complications of transplant. Exclusion Criteria: - Preterm infants (<44 weeks gestation at age of enrollment) as in these patients most bleeding etiologies are specific to the neonatal period and the bleeding assessment tool is not calibrated for this population - Known limitation of care at enrollment (standing Do Not Resuscitate order), as the interventions and clinical outcome would be biased - Pre-existing bleeding disorders

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of severity of bleeding 1 year
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