Clinical trial NCT06820515: ATHNdataset Registry
Official title: American Thrombosis and Hemostasis Network ATHNdataset Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hemophilia
Thrombosis
Hemophilia A
Hemophilia B
Sickle Cell Disease
Glanzmann Thrombasthenia
Bleeding Disorder
Blood Disorder
Von Willebrand Diseases
Keywords: bleed event
bleed treatments
adverse events
joint bleed
bleeding disorder
bleeding symptoms
Lead sponsor: American Thrombosis and Hemostasis Network
Sponsor class: NETWORK
First posted: 2025-02-11
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Any participant unable to provide consent or assent to participate in the ATHNdataset

Primary outcomes:
measure: Comprehensive real-world clinical data registry analysis, research, advocacy, and public health reporting for the blood disorders community
timeFrame: 15 years
Secondary outcomes:
measure: Contribute to scientific and public health reporting for the blood disorders community
timeFrame: 20 years
Other outcomes:
Locations:
city: Hickory
country: United States
facility: American Thrombosis and Hemostasis Network
state: North Carolina
Study officials:
affiliation: American Thrombosis and Hemostasis Network
name: Tammuella Chrisentery-Singleton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: