Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266994
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2005-12-16
Brief Title:
HTRS TE Registry ThromboEmbolism Registry
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
HTRS TE Registry ThromboEmbolism Registry Prospective Registry of Demographic and Clinical Data for Patients With Thromboembolic Disease
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 US population Annually 60000 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 338 Antithrombin AT is the least common 19 of these while Factor V Leiden FVL is the most common 188 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
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 338 Antithrombin AT is the least common 19 of these while Factor V Leiden FVL is the most common 188 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 502305 | None | None | None |