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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00178594
Enrollment
1000
Registered
2005-09-15
Start date
2002-10-31
Completion date
2028-01-31
Last updated
2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation Disorders, Inherited, Thrombotic Disorder

Keywords

Hereditary Bleeding disorder, Thrombotic Disorder

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.

Interventions

None listed

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 98 Years
Healthy volunteers
No

Inclusion criteria

patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent

Exclusion criteria

poor venous access

Design outcomes

Primary

MeasureTime frameDescription
Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders24 hoursCoagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function

Countries

United States

Contacts

Primary ContactKatherine Addy, RN, BSN, MPH
Katherine.E.Addy@uth.tmc.edu713-500-8352
Backup ContactDaisy Garcia, RN, BSN
daisy.r.garcia@uth.tmc.edu713-500-8386

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026