Status:
COMPLETED
HTRS TE Registry (ThromboEmbolism Registry)
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Hemophilia and Thrombosis Research Society
Conditions:
Thromboembolism
Eligibility:
All Genders
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 Reg...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
2760 Patients enrolled
Trial Details
Trial ID
NCT00266994
Start Date
December 1 2005
End Date
October 1 2012
Last Update
February 21 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205