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Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Thrombotic Disorder
Blood Coagulation Disorders, Inherited

Study type

Observational

Funder types

Other

Identifiers

NCT00178594
HSC-MS-02-174

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

1 day to 98 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

2

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Central trial contact

Katherine Addy, RN, BSN, MPH; Daisy Garcia, RN, BSN

Data sourced from clinicaltrials.gov

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