Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

NCT ID: NCT00178594

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-10-31

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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This is an exploratory study involving blood coagulation assays in a select group of individuals receiving treatment for their congenital or acquired bleeding or clotting disorder at UTHealth Houston. 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.

Conditions

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Blood Coagulation Disorders, Inherited Thrombotic Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent

Exclusion Criteria: poor venous access
Minimum Eligible Age

1 Day

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Miguel Escobar

Professor - UTHealth McGovern Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel Escobar, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The Univerisity of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

UT Physicians Women's Center-Texas Medical Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katherine Addy, RN, BSN, MPH

Role: CONTACT

713-500-8352

Daisy Garcia, RN, BSN

Role: CONTACT

713-500-8386

Facility Contacts

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Katherine Addy, RN, BSN, MPH

Role: primary

713-500-8352

Miguel Escobar, MD

Role: backup

Randa Jalloul, MD

Role: primary

(832) 325-7131

Randa Jalloul, MD

Role: backup

Other Identifiers

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HSC-MS-02-174

Identifier Type: -

Identifier Source: org_study_id

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