NCT00178594

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2002

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Oct 2002Jan 2028

Study Start

First participant enrolled

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
22.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 9, 2025

Status Verified

December 1, 2024

Enrollment Period

25.3 years

First QC Date

September 12, 2005

Last Update Submit

January 7, 2025

Conditions

Blood Coagulation Disorders, InheritedThrombotic Disorder

Keywords

Hereditary Bleeding disorderThrombotic Disorder

Outcome Measures

Primary Outcomes (1)

  • Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders

    Coagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function

    24 hours

Eligibility Criteria

Age1 Day - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with an acquired or congenital bleeding disorder or acquired thrombotic disorder receiving treatment for their condition at UTHealth Houston.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Univerisity of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

UT Physicians Women's Center-Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

human whole blood and plasma

MeSH Terms

Conditions

Blood Coagulation Disorders, InheritedThrombosis

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Miguel Escobar, M.D.

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Addy, RN, BSN, MPH

CONTACT

713-500-8352Katherine.E.Addy@uth.tmc.edu

Daisy Garcia, RN, BSN

CONTACT

713-500-8386daisy.r.garcia@uth.tmc.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - UTHealth McGovern Medical School

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

October 1, 2002

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 9, 2025

Record last verified: 2024-12

Locations

US(2)