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Active, Not Recruiting

NCT Number: NCT07560007

The Bleeding Assessment Tool (BAT)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases Von Willebrand Disease (VWD) von Willebrand Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.
  • If patient has multiple BAT+ scores will utilize the BAT+ score done at the new patient Hematology clinic CCHMC

Exclusion criteria

  • Lack of BAT+ on new patient visit in outpatient setting to rule out mild

Treatment and study plan

Primary outcomes

  1. BAT+ Classification

    Time frame: From January 2019, through December 1, 2024

    Dichotomous BAT classification (BAT+ vs BAT-) based on predefined age- and sex-specific BAT cutoffs.

  2. Bleeding Assessment Tool (BAT) Score

    Time frame: From January 2019, through December 1, 2024

    Total BAT score calculated according to standardized criteria to quantify bleeding symptoms.

  3. Probability of Diagnosed Bleeding Disorder Based on BAT Score

    Time frame: From January 2019, through December 1, 2024

    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.

  4. Probability of Diagnosed Bleeding Disorder Based on BAT+ Status

    Time frame: From January 2019, through December 1, 2024

    Predicted pretest probability of a confirmed bleeding disorder diagnosis estimated using logistic regression models with BAT+ classification as the primary predictor.

  5. Confirmed Bleeding Disorder Diagnosis by Category

    Time frame: From January 2019, through December 1, 2024

    Final clinical diagnosis categorized as von Willebrand disease, platelet function disorder, coagulation factor deficiency, fibrinolytic disorder, or no bleeding disorder, using standardized diagnostic criteria.

  6. Diagnostic Accuracy of BAT

    Time frame: From January 2019, through December 1, 2024

    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.

  7. Diagnostic Accuracy of BAT+

    Time frame: From January 2019, through December 1, 2024

    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.

  8. Likelihood Ratios for BAT

    Time frame: From January 2019, through December 1, 2024

    Positive likelihood ratio for BAT at the initial cutoff score of ≥3 and at optimized cutoffs derived from ROC analysis.

  9. Likelihood Ratios for BAT+

    Time frame: From January 2019, through December 1, 2024

    Positive likelihood ratio for BAT+ at the initial cutoff score of ≥6 and at optimized cutoffs derived from ROC analysis.

  10. Area Under the ROC Curve (AUC) for BAT

    Time frame: From January 2019, through December 1, 2024

    Area under the receiver operating characteristic (ROC) curve for BAT scores derived from logistic regression models discriminating confirmed bleeding disorder diagnosis (yes/no).

  11. Area Under the ROC Curve (AUC) for BAT+

    Time frame: From January 2019, through December 1, 2024

    Area under the ROC curve for BAT+ classification derived from logistic regression models discriminating confirmed bleeding disorder diagnosis (yes/no).

  12. Optimized BAT Cutoff Score

    Time frame: From January 2019, through December 1, 2024

    Optimized BAT cutoff score identified using Youden's Index based on ROC curve analysis.

  13. Optimized BAT+ Cutoff Score

    Time frame: From January 2019, through December 1, 2024

    Optimized BAT+ cutoff identified using Youden's Index based on ROC curve analysis.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Acronym: BAT Protocol

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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