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Trombocytopathy in the Netherlands


- candidate number24742
- NTR NumberNTR6051
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2016
- Secondary IDs15-597 NL53207.041.15
- Public TitleTrombocytopathy in the Netherlands
- Scientific TitleTrombocytopathy in the Netherlands
- ACRONYMTiN
- hypothesisObservational study to register and investigate patients in the Netherlands with a (suspected) PFD, to assess clinical presentation, bleeding score, burden of disease and quality of life.
- Healt Condition(s) or Problem(s) studiedPlatelet reactivity, Thrombocytopenia
- Inclusion criteria- Age > 18 years
- History of bleeding diathesis suspected for a PFD
- Exclusion criteria- Inability to give informed consent
- Bleeding diathesis due to an acquired PFD, von Willebrand disease, hemophilia or other disorders of secondary hemostasis or fibrinolysis
- Current use of antiplatelet therapy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 11-feb-2016
- planned closingdate
- Target number of participants150
- InterventionsNone
- Primary outcome- Frequency and severity of bleeding symptoms: bleeding score using the ISTH-BAT
- Treatment of bleeding diathesis: type and frequency of treatment received in the past (local treatment, antifibrinolytics, DDAVP, platelet transfusion)
- Impact of PFD on quality of life: RAND-36 health survey score
- Secondary outcome- Diagnostic utility of additional platelet tests as compared to standard LTA
- Relation between type of PFD and bleeding phenotype
- Genotype-phenotype relationship
- TimepointsNone
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Maaike Blaauwgeers
- CONTACT for SCIENTIFIC QUERIES Roger Schutgens
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryA nationwide cross-sectional study of patients above 18 years of age with a (suspected) PFD will be performed. Frequency and severity of bleeding symptoms will be assessed using the ISTH bleeding assessment tool (BAT). Patients will complete a questionnaire on treatment history, social activities and quality of life, including items of the RAND-36 health survey. Blood will be drawn to perform routine laboratory testing for platelet function and additional tests, including the flow cytometry based Platelet ACtivation Test (PACT), MYH9 immunofluorescence analysis, mepacrine response, perfusion analysis, mass spectrometry and whole-exome sequencing (WES). Plasma will be stored in the biobank for additional testing in the future. This study combines clinical burden, functional assays, WES and mass spectrometry, generating a unique platform to better understand PFDs and to improve patient care.
- Main changes (audit trail)
- RECORD5-aug-2016 - 3-nov-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl