HTRS TE Registry (ThromboEmbolism Registry)

Completed

Conditions studied: Thromboembolism

In brief

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.

Key facts

Study ID

NCT00266994

Run by

Nationwide Children's Hospital

People needed

2760

Starts

2005-12-01

Expected to finish

2012-10-01

Last updated by the study team

2013-02-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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