The Clinical Relevance and Significance of New Diagnostic Options in patients with unexplained bleeding
- Conditions
- bleeding disorderunexplained bleeding tendency10064477
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 330
Patients of all ages;
Patients with a significant history of bleeding tendency according to physician opinion or abnormal bleeding score based on a BAT
o with no defined diagnosis after routine testing (see appendix 4 of the research protocol),
o with a heterozygous factor deficiency or low Von Willebrand Factor levels that do not
correspond with the experienced bleeding tendency,
o with aberrant laboratory results not fitting a diagnosis;
Informed consent should be provided prior to any study specific procedure.
Patients with a defined bleeding disorder after routine testing (see appendix 4 of the research protocol, except when they serve as controls for the trombocytopathy arm);
Patients under therapy with anticoagulants and / or antiplatelet and / or anti-inflammatory agents whom cannot stop their medication during the diagnostic work-up;
Patients with thrombocytopenia < 80 x 109/L (with exception to the patients with suspected or volunteers in the control group with a proven platelet disorder);
Patients with a bleeding tendency due to an acquired platelet function disorder (e.g. idiopathic thrombocytopenic purpura * ITP);
Patients with impaired liver function, eg a documented liver cirrhosis or signs of acute liver failure;
Women that are pregnant or up to three months postpartum;
Patients who are inable to give informed consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the association between the bleeding phenotype (based on medical<br /><br>history and / or bleeding score), new diagnostic tests and bleeding<br /><br>complications during a one year follow-up period.</p><br>
- Secondary Outcome Measures
Name Time Method