Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Coagulation Disorders, Inherited
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 1000
- Locations
- 2
- Primary Endpoint
- Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Miguel Escobar
Professor - UTHealth McGovern Medical School
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent
Exclusion Criteria
- •poor venous access
Outcomes
Primary Outcomes
Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders
Time Frame: 24 hours
Coagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function