ThromboembolismNCT00266994
HTRS TE Registry (ThromboEmbolism Registry)
An observational study of Thromboembolism, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The TE Registry is a multi-institutional bioinformatics database for the collection of data relevant to TE. Participating HTRS affiliated study centers may enroll patients and enter data in the TE Registry by completing enrollment and data entry forms and transmitting them to the study center. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thromboembolism
- How many people
- 2,760 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible patients diagnosed with a thromboembolic event at any of the participating study centers will be invited to participate in this study.
Who may be able to join
- Patients should be enrolled at the time of their FIRST thromboembolic event. Ideally, patients should be enrolled within three months of the diagnosis of an eligible event.
- Deep Venous, Arterial, or Intra-Cardiac Thrombosis
- Pulmonary Thromboembolism AND:
- Must have evidence of Venous Thrombosis on imaging studies -OR-
- Must have elevated Quantitative or Semi-Quantitative D-dimer level (as defined by local laboratory technology/normal ranges)
- Arterial Thromboembolism (with imaging evidence of thrombus source)
- Stroke (Cerebral Vascular Accident) AND age < 20 years. Stroke is defined as a completed stroke with symptoms persisting for > 24 hours and radiographic evidence of infarction by Computed Tomography or Magnetic Resonance Imaging. Transient Ischemic Attacks (TIA) are NOT eligible for this registry.
- Myocardial Infarction AND age <20 years. Must have elevated cardiac enzymes (CK and/or Troponin) and Electrocardiographic (EKG) evidence meeting the local standard for diagnosis. Angina is NOT eligible for this registry.
Who cannot join
- Bleeding disorders
- Transient Ischemic Attack(s) (TIA)
- Sickle Cell Disease
- Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-Like Episodes (MELAS)
- Ornithine Transcarbamylase Deficiency
- Homocystinuria
Show all 12Show fewer
- Other metabolic disorders known to be associated with Stroke
- Hemorrhagic Stroke
- Bacterial Endocarditis
- Microangiopathic Hemolytic Anemias (Thrombotic Thrombocytopenic Purpura or Hemolytic Uremic Syndrome)
- Patients greater than or equal to 20 years of age with Stroke or Myocardial Infarction (in order to limit confounding cardiovascular risk factors)
- Angina
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: HTRS TE Registry (ThromboEmbolism Registry): Prospective Registry of Demographic and Clinical Data for Patients With Thromboembolic Disease
The TE Registry is a multi-institutional bioinformatics database for the collection of data relevant to TE. Participating HTRS affiliated study centers may enroll patients and enter data in the TE Registry by completing enrollment and data entry forms and transmitting them to the study center. The purpose of this study is to improve our understanding of the epidemiology, pathophysiology, and outcome of patients suffering from thromboembolism (TE) events.
The initial objectives of the registry are:
- Evaluate the epidemiology and clinical characteristics of known prothrombotic risk factors in persons with TE.
- Identify the frequency and nature of complications associated with TE and its treatment.
- Describe the phenotypes and complications seen in persons with multiple molecular risk factors for TE.
- Compare the epidemiology, clinical characteristics, and complications seen in patients with and without known risk factors for TE.
Read the detailed description
Hereditary defects that predispose to thromboembolism (TE) and its complications afflict 5-8% of the U.S population. Annually, ~60,000 Americans die from TE and half of the survivors suffer long-term morbidity. Despite these staggering statistics, little is known about the clinical characteristics or epidemiology of the inherited risk factors for TE. Less is known regarding the acquired risk factors or the phenotype of TE in persons with multiple risk factors, yet preliminary data suggest that as many as 10% of patients may have multiple risk factors.
Data from several studies, primarily involving adult subjects, shows that in a population of consecutively studied thrombosis patients, that one of the five most common inherited predispositions will occur in ~33.8%. Antithrombin (AT) is the least common (~1.9%) of these, while Factor V Leiden (FVL) is the most common (~18.8%). Most children who suffer from TE have indwelling catheters to assist therapy of underlying medical conditions, or are sick neonates. Thus, the contribution of molecular risk factors in children is largely unknown, with the exception of sparse retrospective data.
The TE Registry may help clearly define the clinical phenotype, epidemiology, and complications seen in patients with TE associated with known molecular risk factors.
- Conditions
- Thromboembolism
- Keywords
- Thrombosis
- Medical subject headings
- Thromboembolism, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation
Observational cohort study - no primary outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hemophilia and Thrombosis Research Society
- Responsible party
- Principal investigator, Bryce A. Kerlin, Nationwide Children's Hospital
- Investigators
- Bryce A Kerlin, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266994
- Sponsor's protocol ID
- 05-00343
- Other IDs
- 502305
- Status last verified
- Feb 2013
- First submitted
- 16 Dec 2005
- Last updated
- 21 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HTRS TE Registry (ThromboEmbolism Registry): Prospective Registry of Demographic and Clinical Data for Patients With Thromboembolic Disease
- ClinicalTrials.gov ID
- NCT00266994
- Acronym / sponsor ID
- 05-00343
- Conditions
- Thromboembolism
- Keywords
- Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,760 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Hemophilia and Thrombosis Research Society
- Study start
- Dec 2005
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TE Registry is a multi-institutional bioinformatics database for the collection of data relevant to TE. Participating HTRS affiliated study centers may enroll patients and enter data in the TE Registry by completing enrollment and data entry forms and transmitting them to the study center. The purpose of this study is to improve our understanding of the epidemiology, pathophysiology, and outcome of patients suffering from thromboembolism (TE) events.
The initial objectives of the registry are:
- Evaluate the epidemiology and clinical characteristics of known prothrombotic risk factors in persons with TE.
- Identify the frequency and nature of complications associated with TE and its treatment.
- Describe the phenotypes and complications seen in persons with multiple molecular risk factors for TE.
- Compare the epidemiology, clinical characteristics, and complications seen in patients with and without known risk factors for TE.
Detailed description
Hereditary defects that predispose to thromboembolism (TE) and its complications afflict 5-8% of the U.S population. Annually, ~60,000 Americans die from TE and half of the survivors suffer long-term morbidity. Despite these staggering statistics, little is known about the clinical characteristics or epidemiology of the inherited risk factors for TE. Less is known regarding the acquired risk factors or the phenotype of TE in persons with multiple risk factors, yet preliminary data suggest that as many as 10% of patients may have multiple risk factors.
Data from several studies, primarily involving adult subjects, shows that in a population of consecutively studied thrombosis patients, that one of the five most common inherited predispositions will occur in ~33.8%. Antithrombin (AT) is the least common (~1.9%) of these, while Factor V Leiden (FVL) is the most common (~18.8%). Most children who suffer from TE have indwelling catheters to assist therapy of underlying medical conditions, or are sick neonates. Thus, the contribution of molecular risk factors in children is largely unknown, with the exception of sparse retrospective data.
The TE Registry may help clearly define the clinical phenotype, epidemiology, and complications seen in patients with TE associated with known molecular risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients diagnosed with a thromboembolic event at any of the participating study centers will be invited to participate in this study.
Key inclusion criteria (8 listed)
- Patients should be enrolled at the time of their FIRST thromboembolic event. Ideally, patients should be enrolled within three months of the diagnosis of an eligible event.
- Deep Venous, Arterial, or Intra-Cardiac Thrombosis
- Pulmonary Thromboembolism AND:
- Arterial Thromboembolism (with imaging evidence of thrombus source)
- Stroke (Cerebral Vascular Accident) AND age < 20 years. Stroke is defined as a completed stroke with symptoms persisting for > 24 hours and radiographic evidence of infarction by Computed Tomography or Magnetic Resonance Imaging. Transient Ischemic Attacks (TIA) are NOT eligible for this registry.
Key exclusion criteria (12 listed)
- Bleeding disorders
- Transient Ischemic Attack(s) (TIA)
- Sickle Cell Disease
- Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-Like Episodes (MELAS)
- Ornithine Transcarbamylase Deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observation
Time frame: 2 years
Observational cohort study - no primary outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryce A Kerlin, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.