Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses

"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.

Study Overview

• Status: Completed
• Conditions: Cancer; Bleeding

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All subjects admitted to the pediatric ICU at MSKCC will be included in this observational study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incidence of severity of bleeding	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Marianne Nellis, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Critically Ill Children; 19-407
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Hemorrhage; Critical Illness
• Other Study ID Numbers: 19-407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No