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HTRS TE Registry (ThromboEmbolism Registry)

This study has been completed.
Sponsor:
Collaborator:
Hemophilia and Thrombosis Research Society
Information provided by (Responsible Party):
Bryce A. Kerlin, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00266994
First received: December 16, 2005
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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
Thromboembolism

Study Type: Observational
Study Design: 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

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Observation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Observational cohort study - no primary outcome.


Enrollment: 2760
Study Start Date: December 2005
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266994

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

No publications provided

Responsible Party: Bryce A. Kerlin, PI, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00266994     History of Changes
Other Study ID Numbers: 05-00343, 502305
Study First Received: December 16, 2005
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
Thrombosis

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

ClinicalTrials.gov processed this record on November 19, 2014