Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

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.

Recruiting

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Key information

Conditions

Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Thrombosis Thrombotic Disorder Vascular Diseases

Age range

1 day–98 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Univerisity of Texas Health Science Center at Houston, Houston, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

poor venous access

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Daisy Garcia, RN, BSN

CONTACT

[email protected]

713-500-8386

Katherine Addy, RN, BSN, MPH

CONTACT

[email protected]

713-500-8352

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2028
Study completion: 2028
First posted: Sep 15, 2005
Registry last updated: Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed