HTRS TE Registry (ThromboEmbolism Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00266994
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : February 21, 2013
Hemophilia and Thrombosis Research Society
Information provided by (Responsible Party):
Bryce A. Kerlin, Nationwide Children's Hospital

Brief 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. 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.

Condition or disease

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 Type : Observational
Actual Enrollment : 2760 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HTRS TE Registry (ThromboEmbolism Registry): Prospective Registry of Demographic and Clinical Data for Patients With Thromboembolic Disease
Study Start Date : December 2005
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Primary Outcome Measures :
  1. Observation [ Time Frame: 2 years ]
    Observational cohort study - no primary outcome.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients diagnosed with a thromboembolic event at any of the participating study centers will be invited to participate in this study.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Bleeding disorders
  • Transient Ischemic Attack(s) (TIA)
  • Sickle Cell Disease
  • Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-Like Episodes (MELAS)
  • Ornithine Transcarbamylase Deficiency
  • Homocystinuria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00266994

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Hemophilia and Thrombosis Research Society
Principal Investigator: Bryce A Kerlin, MD Nationwide Children's Hospital

Responsible Party: Bryce A. Kerlin, PI, Nationwide Children's Hospital Identifier: NCT00266994     History of Changes
Other Study ID Numbers: 05-00343
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Bryce A. Kerlin, Nationwide Children's Hospital:

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases