Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

This study is currently recruiting participants.
Verified June 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Miguel Escobar, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178594
First received: September 12, 2005
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition
Congenital Bleeding
Thrombotic Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2002
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with an Acquired or Congenital Bleeding Disorder or Acquired Thrombotic Disorder

Criteria

Inclusion Criteria:

  • Congenital or Acquired Bleeding Disorder Congenital or Acquired Thrombotic Disorder

Exclusion Criteria:

  • Poor venous access
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178594

Contacts
Contact: Madeline Cantini, BSN 713-500-8377 madeline.cantini@uth.tmc.edu

Locations
United States, Texas
The Univerisity of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Madeline Cantini, BSN    713-500-8377    madeline.cantini@uth.tmc.edu   
Principal Investigator: Miguel Escobar, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Miguel Escobar, M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Miguel Escobar, Associate Professor - Gulf States Hemophilia Center, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178594     History of Changes
Other Study ID Numbers: Roteg
Study First Received: September 12, 2005
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Congenital Bleeding
Thrombotic Disorder

Additional relevant MeSH terms:
Hemorrhage
Thrombosis
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014