ClinicalTrials.gg
RecruitingNCT00178594Updated Jan 9, 2025

Evaluation of Hemostasis in Bleeding and Thrombotic Disorders

An observational study in Blood Coagulation Disorders, Inherited and Thrombotic Disorder, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 2 sites in United States. Open to participants aged 1 Day to 98 Years. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by The University of Texas Health Science Center, Houston · Observational

From the registry’s dates

  • Started Oct 2002; still recruiting 24 years 1 month later.

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
1 Day to 98 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 14 studies in Blood Coagulation Disorders, Inherited with a site in United States — 3 open to participants now, 3 under way, 1 of them phase 3. Blood Coagulation Disorders, Inherited · United States.

Started
2002
the only one that year
Observational
4 of 14
2 open now
Registered
1st of 14
by date
Lead sponsor
1 of 14
The University of Texas Health Science Center, Houston

Among the 14 studies in Blood Coagulation Disorders, Inherited with a site in United States, this one is the only one that started in 2002, is one of 4 observational ones, and was the 1st registered.

Blood Coagulation Disorders, Inherited

21 studies on the registry are indexed under Blood Coagulation Disorders, Inherited; 4 are open to participants now.

Browse Blood Coagulation Disorders, Inherited studies →

Open to participants now

3 of the 14 studies in Blood Coagulation Disorders, Inherited with a site in United States are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 2 Blood Coagulation Disorders, Inherited studies recruiting now, none set no upper age limit and 1 stops at 75 or younger; 2 take children under 18; none take healthy volunteers.

This study: 1 Day to 98 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Blood Coagulation Disorders, Inherited
  • Thrombotic Disorder

Keywords

  • Hereditary Bleeding disorder
  • Thrombotic Disorder
04

Who can participate

Ages eligible
1 Day to 98 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Eligibility criteria

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

Exclusion Criteria: poor venous access

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

    Time frame: 24 hours

07

Study locations

2 of 2 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided at this time

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2002 (actual). Primary completion is estimated for Jan 2028, 303 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 15, 2005
StartActual
Oct 2002
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Jan 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00178594
Responsible party
Miguel Escobar (Professor - UTHealth McGovern Medical School, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Sep 15, 2005
Start date
Oct 2002
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Jan 9, 2025

Study contacts

Katherine Addy, RN, BSN, MPH
Contact
Katherine.E.Addy@uth.tmc.edu
713-500-8352
Daisy Garcia, RN, BSN
Contact
daisy.r.garcia@uth.tmc.edu
713-500-8386
Miguel Escobar, M.D.
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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