Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 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: May 10, 2016
Last verified: May 2016
  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
Blood Coagulation Disorders, Inherited
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 2020
Estimated Primary Completion Date: January 2020 (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

Ages Eligible for Study:   up to 98 Years   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 
Study First Received: September 12, 2005
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Undecided at this time

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016