HemophiliaNCT06820515
ATHNdataset Registry
An observational study of Hemophilia and Thrombosis, run by American Thrombosis and Hemostasis Network at 1 site in United States.
Trial summary
The Hemophilia Treatment Center (HTC) where you receive care is working with The American Thrombosis and Hemostasis Network (ATHN) to look at the quality of life of people with blood disorders and problems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia, Thrombosis, Hemophilia A
- How many people
- 200,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to 31 Oct 2055
- 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
- Child, Adult, Older adult
Study population: * Data from participants who have previously provided authorization or consent (according to local requirements) and contributed data to the ATHNdataset will be retained. These participants will be offered a chance to provide updated consent if possible. * All future participants from ATHN Affiliates, who meet eligibility criteria and are able to provide consent or assent, will be enrolled prospectively. * Participants who have previously contributed data to the ATHNdataset under the terms of an authorization form, an informed consent form, or an assent form will be offered an opportunity to consent.
Who may be able to join
- Any participant evaluated for or the potential to have a blood disorder who has an encounter with an ATHN Affiliate.
- Participants of any age.
- Participant is able to provide consent or assent; a Legally Authorized Representative (LAR) may provide consent on a participant's behalf if a participant is unable to provide self-consent
Who cannot join
- Any participant unable to provide consent or assent to participate in the ATHNdataset
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
American Thrombosis and Hemostasis Network
Hickory, North Carolina, 28601
Carol Fedor, ND, RN, cfedor@athn.org
About this study
Official title: American Thrombosis and Hemostasis Network ATHNdataset Registry
The Hemophilia Treatment Center (HTC) where you receive care is working with The American Thrombosis and Hemostasis Network (ATHN) to look at the quality of life of people with blood disorders and problems.
Doctors, scientists, policymakers, and other health care providers need a large amount of information from a lot of people to answer scientific, public health, and policy questions about better ways to treat blood disorders. They will use the information from the ATHNdataset to answer these questions.
Read the detailed description
Participants who agree to participate will let their health information be included in the ATHNdataset Registry, and the information will be updated regularly to reflect the participant's current health status. This registry includes collecting, storing and managing health information through a secure database. The following health information will be collected:
- Demographics (e.g., age, gender, income, education/occupation)
- The type of blood disorder you have
- Date you were diagnosed, or symptoms began
- Family history of the disorder
- Testing and assessments
- Physical exams
- Height, weight
- Vital signs, including blood pressure and heart rate
- Laboratory tests (results from blood or urine testing, or biological specimens)
- Genetic test results
- Imaging results (X-rays, CT scans, etc.)
- Pharmacokinetic testing results (how drugs are processed in the body)
- Medications used and any problems with use
- Types of bleeds, pain and clotting problems
- Treatments that stop your bleeding or clotting problems from occurring or getting worse
- Surgeries and/or procedures
- Immunizations (vaccines)
- Devices
- Routine care visits and injuries (trauma)
- Other illnesses and diseases you may have
- Allergies
- Patient-reported outcomes (PROs), questionnaires, and surveys
- Payment details for treatment, including insurance companies and health plans
- Conditions
- Hemophilia, Thrombosis, Hemophilia A, Hemophilia B, Sickle Cell Disease, Glanzmann Thrombasthenia
- Keywords
- bleed event, bleed treatments, adverse events, joint bleed, bleeding disorder, bleeding symptoms
- Medical subject headings
- Hemophilia A, Thrombosis, Hemophilia B, Anemia, Sickle Cell, Thrombasthenia, Hemostatic Disorders, Hematologic Diseases, 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 |
|---|---|---|
| Blood Disorders | The ATHNdataset is a large, robust real-world registry that can be queried to produce curated subsets of data to support clinical care, outcomes analysis, safety monitoring, practice of treatment, advocacy, public health reporting, quality improvement projects, and research initiatives. Initiatives relying on the ATHNdataset may focus on gaining a greater understanding of blood disorders, the complications of these disorders, their social and economic costs, and the effectiveness of treatments. The population includes all individuals diagnosed with or suspected to have a blood disorder. Participants will contribute data gathered during care encounters with an ATHN Affiliate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive real-world clinical data registry analysis, research, advocacy, and public health reporting for the blood disorders community
The ATHNdataset Registry objective is to develop a secure, comprehensive registry of real-world clinical data to support standardized comprehensive health information for persons living with blood disorders and public health reporting for the blood disorders community
Measured: 15 years
Secondary outcomes (1)
Contribute to scientific and public health reporting for the blood disorders community
By providing a comprehensive registry for physicians, scientists, policy makers, and other health care stakeholders who require a large pool of participant information to answer questions related to blood disorders treatments
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start25 Oct 2024
- Primary completion25 Oct 2054 (estimated)
- Study completion31 Oct 2055 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- Prospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Thrombosis and Hemostasis Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tammuella Chrisentery-Singleton, M.D., Principal investigator, American Thrombosis and Hemostasis Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820515
- Sponsor's protocol ID
- Pro00082318
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- American Thrombosis and Hemostasis Network ATHNdataset Registry
- ClinicalTrials.gov ID
- NCT06820515
- Acronym / sponsor ID
- Pro00082318
- Conditions
- Hemophilia, Thrombosis, Hemophilia A, Hemophilia B, Sickle Cell Disease, Glanzmann Thrombasthenia
- Keywords
- bleed event, bleed treatments, adverse events, joint bleed, bleeding disorder, bleeding symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- American Thrombosis and Hemostasis NetworkResearch network
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 25 Oct 2054 (estimated)
- Study completion
- 31 Oct 2055 (estimated)
- First posted
- 11 Feb 2025 (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.
The Hemophilia Treatment Center (HTC) where you receive care is working with The American Thrombosis and Hemostasis Network (ATHN) to look at the quality of life of people with blood disorders and problems.
Doctors, scientists, policymakers, and other health care providers need a large amount of information from a lot of people to answer scientific, public health, and policy questions about better ways to treat blood disorders. They will use the information from the ATHNdataset to answer these questions.
Detailed description
Participants who agree to participate will let their health information be included in the ATHNdataset Registry, and the information will be updated regularly to reflect the participant's current health status. This registry includes collecting, storing and managing health information through a secure database. The following health information will be collected:
- Demographics (e.g., age, gender, income, education/occupation)
- The type of blood disorder you have
- Date you were diagnosed, or symptoms began
- Family history of the disorder
- Testing and assessments
- Physical exams
- Height, weight
- Vital signs, including blood pressure and heart rate
- Laboratory tests (results from blood or urine testing, or biological specimens)
- Genetic test results
- Imaging results (X-rays, CT scans, etc.)
- Pharmacokinetic testing results (how drugs are processed in the body)
- Medications used and any problems with use
- Types of bleeds, pain and clotting problems
- Treatments that stop your bleeding or clotting problems from occurring or getting worse
- Surgeries and/or procedures
- Immunizations (vaccines)
- Devices
- Routine care visits and injuries (trauma)
- Other illnesses and diseases you may have
- Allergies
- Patient-reported outcomes (PROs), questionnaires, and surveys
- Payment details for treatment, including insurance companies and health plans
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Disorders | – | –The ATHNdataset is a large, robust real-world registry that can be queried to produce curated subsets of data to support clinical care, outcomes analysis, safety monitoring, practice of treatment, advocacy, public health reporting, quality improvement projects, and research initiatives. Initiatives relying on the ATHNdataset may focus on gaining a greater understanding of blood disorders, the complications of these disorders, their social and economic costs, and the effectiveness of treatments. The population includes all individuals diagnosed with or suspected to have a blood disorder. Participants will contribute data gathered during care encounters with an ATHN Affiliate. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * Data from participants who have previously provided authorization or consent (according to local requirements) and contributed data to the ATHNdataset will be retained. These participants will be offered a chance to provide updated consent if possible. * All future participants from ATHN Affiliates, who meet eligibility criteria and are able to provide consent or assent, will be enrolled prospectively. * Participants who have previously contributed data to the ATHNdataset under the terms of an authorization form, an informed consent form, or an assent form will be offered an opportunity to consent.
Key inclusion criteria (3 listed)
- Any participant evaluated for or the potential to have a blood disorder who has an encounter with an ATHN Affiliate.
- Participants of any age.
- Participant is able to provide consent or assent; a Legally Authorized Representative (LAR) may provide consent on a participant's behalf if a participant is unable to provide self-consent
Key exclusion criteria (1 listed)
- Any participant unable to provide consent or assent to participate in the ATHNdataset
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
Comprehensive real-world clinical data registry analysis, research, advocacy, and public health reporting for the blood disorders community
Time frame: 15 years
The ATHNdataset Registry objective is to develop a secure, comprehensive registry of real-world clinical data to support standardized comprehensive health information for persons living with blood disorders and public health reporting for the blood disorders community
1 secondary outcome
Contribute to scientific and public health reporting for the blood disorders community
Time frame: 20 years
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 21 Apr 2026.
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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.
Tammuella Chrisentery-Singleton, M.D. principal investigator
American Thrombosis and Hemostasis Network
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 Hemophilia and Thrombosis, run by American Thrombosis and Hemostasis Network 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 3 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: looking for participants now, as of the sponsor's last update on 21 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?
Contact Emily Callegari, RN (8003602846 ext. 124, ecallegari@athn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive real-world clinical data registry analysis, research, advocacy, and public health reporting for the blood disorders community (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.