Evaluation of Hemostasis in Bleeding and Thrombotic Disorders
- Conditions
- Blood Coagulation Disorders, InheritedThrombotic Disorder
- Registration Number
- NCT00178594
- Brief Summary
The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.
- Detailed Description
This is an exploratory study involving blood coagulation assays in a select group of individuals receiving treatment for their congenital or acquired bleeding or clotting disorder at UTHealth Houston. The ROTEG is a newly developed coagulation analyzer which allows the continuous assessment of whole blood coagulation from the formation of the first fibrin fibers and activated platelets, to the formation of a three-dimensional whole blood clot until the eventual dissolution of the clot. This device will not be used as a diagnostic or procedure tool. No recommendations regarding interpretation of the results or implications for future treatment will be provided.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent
poor venous access
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders 24 hours Coagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The Univerisity of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
UT Physicians Women's Center-Texas Medical Center
🇺🇸Houston, Texas, United States