NCT00178594

Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 1 Day – 98 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Coagulation Disorders, Inherited
• Thrombotic Disorder

Timeline

• Start date: 2002-10-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2005-09-15
• Last updated: 2025-01-09

Locations

2 sites across 1 country: United States