No registrations found.
ID
Source
Brief title
Health condition
chronic ITP
platelet function
Immune thrombocytopenia
fatigue
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess platelet function and coagulation parameters in adult chronic ITP patients in relation to their bleeding phenotype
Secondary outcome
-To assess immune profiles in chronic ITP patients and explore for imbalances between effector cells and regulatory cells
-To validate the CIS-20 fatigue subscale in chronic ITP patients by comparing it to the FACIT-F
-To assess the prevalence of menorrhagia in female chronic IT patients and the impact on daily life
-To compare fatigue in chronic ITP patients with fatigue in healthy controls and other chronically ill patients
Background summary
In the current proposal, our primary objective is to study the platelet function and the correlation with bleeding phenotype in chronic ITP patients. This might add to platelet count alone in order to understand which patients are at risk of significant bleeding or need treatment. Secondary, we will assess imbalances in the patients’ immunologic profiles in patients with chronic ITP, the extent of fatigue and menstrual problems and the internal consistency of the fatigue subscale of the CIS-20. These results will increase insight in which areas are feasible for future (interventional) research.
Study objective
In the current proposal, our primary objective is to study the platelet function and the correlation with bleeding phenotype in chronic ITP patients. This might add to platelet count alone in order to understand which patients are at risk of significant bleeding or need treatment. Secondary, we will assess imbalances in the patients’ immunologic profiles in patients with chronic ITP, the extent of fatigue and menstrual problems and the internal consistency of the fatigue subscale of the CIS-20. These results will increase insight in which areas are feasible for future (interventional) research.
Study design
1 timepoint (cross-sectional study)
Intervention
An extra blood sample withdrawal during a routine venipuncture (as part of standard of care), the ITP-bleeding assessment tool (ITP-BAT) and two questionnaires. Women will be asked to fill out an extra questionnaire regarding their menstruation and to count the use of sanitary pads and/or tampons during one month (PBAC).
Wobke Dijk, van
Postbus 85500
Utrecht 3508 GA
The Netherlands
0887567846
W.E.M.vanDijk-16@umcutrecht.nl
Wobke Dijk, van
Postbus 85500
Utrecht 3508 GA
The Netherlands
0887567846
W.E.M.vanDijk-16@umcutrecht.nl
Inclusion criteria
-Age 16 years and older
-Previously confirmed diagnosis of chronic primary ITP with current platelet counts of <100x109/L or currently on (any) treatment for chronic ITP
-Willing and able to understand the study information and sign the informed consent form.
Exclusion criteria
There are no additional exclusion criteria
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7200 |
| NTR-old | NTR7399 |
| CCMO | NL66313.041.18 |
| OMON | NL-OMON52965 |