An observational study in Bleeding Disorder and Von Willebrand Disease (VWD), sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
This study looks at whether adding simple family history questions to a standard bleeding questionnaire can better identify children who truly have mild bleeding disorders. Because young children often haven't had major bleeding challenges yet, their own symptoms may not tell the full story, so family history could provide important extra information. By reviewing several years of clinic data, the researchers aim to see if this combined approach helps doctors decide more accurately who needs further testing, especially in children under 8 years old.
This study focuses on improving how doctors evaluate children who may have a mild bleeding disorder, such as von Willebrand disease or platelet function disorders. Doctors already use a standardized bleeding questionnaire to record a child's bleeding symptoms, but this can be difficult in younger children who often haven't had major bleeding challenges like surgery or dental work. To address this, the researchers added a small number of family history questions to the existing tool to see if knowing about bleeding problems in relatives helps predict whether a child truly has a bleeding disorder.
The study reviews several years of existing medical records from children and young adults seen in a pediatric hematology clinic. By comparing the standard questionnaire with the expanded version that includes family history, the researchers want to see which approach more accurately identifies patients who go on to receive a confirmed diagnosis. The goal is to help clinicians decide more confidently who needs further testing and who does not, reducing unnecessary and costly lab work while improving diagnosis, especially for children under 8 years old, where bleeding symptoms alone may be misleading.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 229 observational studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
- All individuals seen at CCHMC CBDI clinic for mild bleeding disorder with completed BAT+ at their new patient visit to Cincinnati Children's Hospital Medical Center (Base Campus or Liberty Campus) since 2019.
Exclusion Criteria:
-All individuals seen at CCHMC CBDI clinic for mild bleeding disorder with completed BAT+ at their new patient visit to Cincinnati Children's Hospital Medical Center (Base Campus or Liberty Campus) since 2019.
BAT+ Classification
Dichotomous BAT classification (BAT+ vs BAT-) based on predefined age- and sex-specific BAT cutoffs.
Time frame: From January 2019, through December 1, 2024
Bleeding Assessment Tool (BAT) Score
Total BAT score calculated according to standardized criteria to quantify bleeding symptoms.
Time frame: From January 2019, through December 1, 2024
Probability of Diagnosed Bleeding Disorder Based on BAT Score
Predicted pretest probability of a confirmed bleeding disorder diagnosis (vWD, platelet function disorder, coagulation factor deficiency, or fibrinolytic disorder) estimated using logistic regression models with BAT score as a continuous predictor.
Time frame: From January 2019, through December 1, 2024
Probability of Diagnosed Bleeding Disorder Based on BAT+ Status
Predicted pretest probability of a confirmed bleeding disorder diagnosis estimated using logistic regression models with BAT+ classification as the primary predictor.
Time frame: From January 2019, through December 1, 2024
Confirmed Bleeding Disorder Diagnosis by Category
Final clinical diagnosis categorized as von Willebrand disease, platelet function disorder, coagulation factor deficiency, fibrinolytic disorder, or no bleeding disorder, using standardized diagnostic criteria.
Time frame: From January 2019, through December 1, 2024
Diagnostic Accuracy of BAT
Diagnostic accuracy of the Bleeding Assessment Tool (BAT) for identifying a confirmed bleeding disorder, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), using an initial cutoff score of ≥3. Optimized cutoff scores will be reassessed using ROC analysis and Youden's Index.
Time frame: From January 2019, through December 1, 2024
Diagnostic Accuracy of BAT+
Diagnostic accuracy of the BAT+ classification for identifying a confirmed bleeding disorder, including sensitivity, specificity, PPV, and NPV, using an initial cutoff score of ≥6. Optimized cutoffs will be reassessed using ROC analysis and Youden's Index.
Time frame: From January 2019, through December 1, 2024
Likelihood Ratios for BAT
Positive likelihood ratio for BAT at the initial cutoff score of ≥3 and at optimized cutoffs derived from ROC analysis.
Time frame: From January 2019, through December 1, 2024
Likelihood Ratios for BAT+
Positive likelihood ratio for BAT+ at the initial cutoff score of ≥6 and at optimized cutoffs derived from ROC analysis.
Time frame: From January 2019, through December 1, 2024
Area Under the ROC Curve (AUC) for BAT
Area under the receiver operating characteristic (ROC) curve for BAT scores derived from logistic regression models discriminating confirmed bleeding disorder diagnosis (yes/no).
Time frame: From January 2019, through December 1, 2024
Area Under the ROC Curve (AUC) for BAT+
Area under the ROC curve for BAT+ classification derived from logistic regression models discriminating confirmed bleeding disorder diagnosis (yes/no).
Time frame: From January 2019, through December 1, 2024
Optimized BAT Cutoff Score
Optimized BAT cutoff score identified using Youden's Index based on ROC curve analysis.
Time frame: From January 2019, through December 1, 2024
Optimized BAT+ Cutoff Score
Optimized BAT+ cutoff identified using Youden's Index based on ROC curve analysis.
Time frame: From January 2019, through December 1, 2024
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati