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Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

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ClinicalTrials.gov Identifier: NCT00178594
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Miguel Escobar, The University of Texas Health Science Center, Houston

Brief 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.

Condition or disease
Blood Coagulation Disorders, Inherited Thrombotic Disorder

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay
Study Start Date : October 2002
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 98 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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: Rotem
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided at this time

Keywords provided by Miguel Escobar, The University of Texas Health Science Center, Houston:
Hereditary Bleeding disorder
Thrombotic Disorder

Additional relevant MeSH terms:
Disease
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Thrombosis
Blood Coagulation Disorders, Inherited
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Embolism and Thrombosis
Genetic Diseases, Inborn
Hemostatics
Coagulants