Bleeding DisorderBAT ProtocolNCT07560007
The Bleeding Assessment Tool (BAT)
An observational study of Bleeding Disorder and Von Willebrand Disease (VWD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bleeding Disorder, Von Willebrand Disease (VWD)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2025to 5 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: - 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.
Who may be able to join
- 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
Who cannot join
- Lack of BAT+ on new patient visit in outpatient setting to rule out mild
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the detailed description
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.
- Conditions
- Bleeding Disorder, Von Willebrand Disease (VWD)
- Keywords
- ISTH-BAT, Bleeding Disorder, bleeding assessment, pediatric bleeding
- Medical subject headings
- Hemostatic Disorders, von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BAT CBDI patients | -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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT+ Classification
Dichotomous BAT classification (BAT+ vs BAT-) based on predefined age- and sex-specific BAT cutoffs.
Measured: From January 2019, through December 1, 2024
Bleeding Assessment Tool (BAT) Score
Total BAT score calculated according to standardized criteria to quantify bleeding symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From January 2019, through December 1, 2024
Optimized BAT+ Cutoff Score
Optimized BAT+ cutoff identified using Youden's Index based on ROC curve analysis.
Measured: From January 2019, through December 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start9 Oct 2025
- Primary completion5 Jul 2026 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bleeding DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560007
- Sponsor's protocol ID
- BAT Protocol: 2025-0160
- Acronym
- BAT Protocol
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Brien SH. An update on pediatric bleeding disorders: bleeding scores, benign joint hypermobility, and platelet function testing in the evaluation of the child with bleeding symptoms. Am J Hematol. 2012 May;87 Suppl 1:S40-4. doi: 10.1002/ajh.23157. Epub 2012 Mar 28.
PubMed 22460356Castaman G, Eikenboom JC, Bertina RM, Rodeghiero F. Inconsistency of association between type 1 von Willebrand disease phenotype and genotype in families identified in an epidemiological investigation. Thromb Haemost. 1999 Sep;82(3):1065-70.
PubMed 10494765Hayward CP. Diagnosis and management of mild bleeding disorders. Hematology Am Soc Hematol Educ Program. 2005:423-8. doi: 10.1182/asheducation-2005.1.423.
PubMed 16304414Sramek A, Eikenboom JC, Briet E, Vandenbroucke JP, Rosendaal FR. Usefulness of patient interview in bleeding disorders. Arch Intern Med. 1995 Jul 10;155(13):1409-15.
PubMed 7794090Rodeghiero F, Tosetto A, Castaman G. How to estimate bleeding risk in mild bleeding disorders. J Thromb Haemost. 2007 Jul;5 Suppl 1:157-66. doi: 10.1111/j.1538-7836.2007.02520.x.
PubMed 17635722Bui J, Martyres D, James PD, Grabell J, Wu J, Steele M, Silva M, Rand ML, Blanchette VS, Barrowman N, Klaassen RJ. Validation of the school age self-administered pediatric bleeding questionnaire (Self-PBQ) in children aged 8-12 years. Pediatr Blood Cancer. 2019 Jun;66(6):e27709. doi: 10.1002/pbc.27709. Epub 2019 Mar 22.
PubMed 30900820Bowman M, Riddel J, Rand ML, Tosetto A, Silva M, James PD. Evaluation of the diagnostic utility for von Willebrand disease of a pediatric bleeding questionnaire. J Thromb Haemost. 2009 Aug;7(8):1418-21. doi: 10.1111/j.1538-7836.2009.03499.x. Epub 2009 May 30. No abstract available.
PubMed 19496919Rydz N, James PD. The evolution and value of bleeding assessment tools. J Thromb Haemost. 2012 Nov;10(11):2223-9. doi: 10.1111/j.1538-7836.2012.04923.x.
PubMed 22974079Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available.
PubMed 20626619
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bleeding Assessment Tool (BAT)
- ClinicalTrials.gov ID
- NCT07560007
- Acronym / sponsor ID
- BAT Protocol / BAT Protocol: 2025-0160
- Conditions
- Bleeding Disorder, Von Willebrand Disease (VWD)
- Keywords
- ISTH-BAT, Bleeding Disorder, bleeding assessment, pediatric bleeding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 5 Jul 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT CBDI patients | – | –-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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of BAT+ on new patient visit in outpatient setting to rule out mild
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 22460356O'Brien SH. An update on pediatric bleeding disorders: bleeding scores, benign joint hypermobility, and platelet function testing in the evaluation of the child with bleeding symptoms. Am J Hematol. 2012 May;87 Suppl 1:S40-4. doi: 10.1002/ajh.23157. Epub 2012 Mar 28.
- Background: PubMed 10494765Castaman G, Eikenboom JC, Bertina RM, Rodeghiero F. Inconsistency of association between type 1 von Willebrand disease phenotype and genotype in families identified in an epidemiological investigation. Thromb Haemost. 1999 Sep;82(3):1065-70.
- Background: PubMed 16304414Hayward CP. Diagnosis and management of mild bleeding disorders. Hematology Am Soc Hematol Educ Program. 2005:423-8. doi: 10.1182/asheducation-2005.1.423.
- Background: PubMed 7794090Sramek A, Eikenboom JC, Briet E, Vandenbroucke JP, Rosendaal FR. Usefulness of patient interview in bleeding disorders. Arch Intern Med. 1995 Jul 10;155(13):1409-15.
- Background: PubMed 17635722Rodeghiero F, Tosetto A, Castaman G. How to estimate bleeding risk in mild bleeding disorders. J Thromb Haemost. 2007 Jul;5 Suppl 1:157-66. doi: 10.1111/j.1538-7836.2007.02520.x.
- Background: PubMed 30900820Bui J, Martyres D, James PD, Grabell J, Wu J, Steele M, Silva M, Rand ML, Blanchette VS, Barrowman N, Klaassen RJ. Validation of the school age self-administered pediatric bleeding questionnaire (Self-PBQ) in children aged 8-12 years. Pediatr Blood Cancer. 2019 Jun;66(6):e27709. doi: 10.1002/pbc.27709. Epub 2019 Mar 22.
- Background: PubMed 19496919Bowman M, Riddel J, Rand ML, Tosetto A, Silva M, James PD. Evaluation of the diagnostic utility for von Willebrand disease of a pediatric bleeding questionnaire. J Thromb Haemost. 2009 Aug;7(8):1418-21. doi: 10.1111/j.1538-7836.2009.03499.x. Epub 2009 May 30. No abstract available.
- Background: PubMed 22974079Rydz N, James PD. The evolution and value of bleeding assessment tools. J Thromb Haemost. 2012 Nov;10(11):2223-9. doi: 10.1111/j.1538-7836.2012.04923.x.
- Background: PubMed 20626619Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Bleeding Disorder
RecruitingPhase 1
A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
Myeloproliferative Neoplasms (MPNs)
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
Active, not recruiting
Auricular VNS Following Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
RecruitingPhase 2
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
Accelerated Phase Myeloproliferative Neoplasm, Blast Phase Myeloproliferative Neoplasm
Not yet recruiting
Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
Sepsis, Disseminated Intravascular Coagulation (DIC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding Disorder and Von Willebrand Disease (VWD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BAT+ Classification (time frame: From January 2019, through December 1, 2024). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07560007, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.