Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay
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.
Status: Recruiting (N/A). Started on October 1st, 2002.
Enrollment: 100 subjects
Study Type: Observational
Study Design:
- Time Perspective: Prospective
Conditions:
Interventions:
Eligibility
Inclusion Criteria:
- Congenital or Acquired Bleeding Disorder Congenital or Acquired Thrombotic Disorder
Exclusion Criteria:
- Poor venous access
- Gender
Both
- Mininum Age
N/A
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: The University of Texas Health Science Center, Houston
Authority: United States: Institutional Review Board
Locations
-
The Univerisity of Texas Health Science Center at Houston
Houston
Texas
77030
United States
Officials
Miguel Escobar, M.D. (Principal Investigator, The University of Texas Health Science Center, Houston)
Sponsors
The University of Texas Health Science Center, Houston (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- January 1st, 2011
- First Received
- January 31st, 2011
- Last Changed
- January 31st, 2011
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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