Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

Blood Coagulation Disorders, Inherited Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00178594
• Other study ID #: HSC-MS-02-174
• Status: Recruiting
• Start date: October 2002
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Katherine Addy, RN, BSN, MPH
• Phone: 713-500-8352
• Email: Katherine.E.Addy[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is an exploratory study involving blood coagulation assays in a select group of individuals. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 98 Years

Eligibility

Inclusion Criteria:

• Congenital or Acquired Bleeding Disorder Congenital or Acquired Thrombotic Disorder

Exclusion Criteria:

• Poor venous access

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Blood Coagulation Disorders, Inherited
• Disease
• Hemorrhage
• Hemostatic Disorders
• Thrombosis
• Thrombotic Disorder

Locations

Country	Name	City	State
United States	The Univerisity of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders	Coagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function	24 hours