Prospective bleeding study in Glanzmann's thrombasthenia

A prospective, observational study of bleeding and quality of life in subjects with Glanzmann thrombasthenia in the United Kingdom

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15050281

Enrollment

Registered

2023-09-28

Start date

2022-05-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glanzmann's thrombasthenia Haematological Disorders

Interventions

The researchers will ask participants to undertake quality-of-life assessments to explore the effects of their symptoms. They will then be asked to complete a detailed daily diary for 3 months to docu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Each participant must meet all of the following inclusion criteria to be eligible for enrollment in the study: 1. Participant has signed the informed consent form 2. =16 years of age 3. Participant has confirmed GT (documented diagnosis on patient held registry document or clinical record) 4. Participant has sufficient English language skills to complete the consent process, electronic questionnaires, and diary

Exclusion criteria

Exclusion criteria: Each participant must not meet any of the following exclusion criteria to be eligible for enrolment in the study: 1. Participant is currently pregnant 2. Participant has a cancer diagnosis (excluding benign or localized disease eg. basal cell carcinoma of the skin) and is currently undergoing systemic treatment 3. Participant has renal impairment currently requiring renal replacement therapy 4. Participant has liver disease currently requiring treatment 5. Participant has heart disease currently requiring treatment 6. Participant is receiving current treatment with anticoagulation or anti-platelet therapies

Design outcomes

Primary

Measure	Time frame
1. Quantitative assessment of bleeding using the International Society on Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH-BAT) at baseline 2. Clinical outcomes over 3 months of observation, including: 2.1. Number of bleeding events measured using daily electronic bleed diary 2.2. Sites of bleeding events measured using daily electronic bleed diary 2.3. Treatments administered for bleeding events measured using daily electronic bleed diary 2.4 Number of hospitalizations due to bleeding events measured using daily electronic bleed diary 4. Quality of life measured at baseline using: 4.1. Patient-Reported Outcomes Measurement Information System (PROMIS)-29 4.2. Menstrual Impact Questionnaire (MIQ) 5. Social outcomes, including missed work, school, and activities, measured using [daily electronic bleed diary] over 3 months of observation	—

Measure

Time frame

1. Quantitative assessment of bleeding using the International Society on Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH-BAT) at baseline 2. Clinical outcomes over 3 months of observation, including: 2.1. Number of bleeding events measured using daily electronic bleed diary 2.2. Sites of bleeding events measured using daily electronic bleed diary 2.3. Treatments administered for bleeding events measured using daily electronic bleed diary 2.4 Number of hospitalizations due to bleeding events measured using daily electronic bleed diary 4. Quality of life measured at baseline using: 4.1. Patient-Reported Outcomes Measurement Information System (PROMIS)-29 4.2. Menstrual Impact Questionnaire (MIQ) 5. Social outcomes, including missed work, school, and activities, measured using [daily electronic bleed diary] over 3 months of observation

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026