Bleeding in Critically Ill Children With Underlying Oncologic Diagnoses
1 other identifier
observational
93
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2019
CompletedFirst Submitted
Initial submission to the registry
November 19, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2023
CompletedOctober 19, 2023
October 1, 2023
3.9 years
November 19, 2019
October 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of severity of bleeding
1 year
Eligibility Criteria
All subjects admitted to the pediatric ICU at MSKCC will be included in this observational study.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Nellis, MD, MS
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2019
First Posted
November 20, 2019
Study Start
November 18, 2019
Primary Completion
October 18, 2023
Study Completion
October 18, 2023
Last Updated
October 19, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
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.