Evaluation of Hemostasis in Bleeding and Thrombotic Disorders
Verified May 2014 by The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Miguel Escobar, The University of Texas Health Science Center, Houston
First received: September 12, 2005
Last updated: May 16, 2014
Last verified: May 2014
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.
Hereditary Bleeding Disorder
||Time Perspective: Prospective
||Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects with an Acquired or Congenital Bleeding Disorder or Acquired Thrombotic Disorder
- Congenital or Acquired Bleeding Disorder Congenital or Acquired Thrombotic Disorder
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
|The Univerisity of Texas Health Science Center at Houston
|Houston, Texas, United States, 77030 |
|Contact: Madeline Cantini, BSN 713-500-8377 firstname.lastname@example.org |
|Principal Investigator: Miguel Escobar, MD |
The University of Texas Health Science Center, Houston
||Miguel Escobar, M.D.
||The University of Texas Health Science Center, Houston
No publications provided
||Miguel Escobar, Associate Professor - Gulf States Hemophilia Center, The University of Texas Health Science Center, Houston
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||May 16, 2014
||United States: Institutional Review Board
Keywords provided by The University of Texas Health Science Center, Houston:
Hereditary Bleeding disorder
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Blood Coagulation Disorders
Embolism and Thrombosis