Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001927
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Study of Abnormal Blood Clotting in Children With Stroke
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Abnormal Acquired and Genetic Coagulation Factors in Children With Porencephaly and Stroke
Status:
COMPLETED
Status Verified Date:
2011-05-04
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:
Effective treatment and prevention strategies for childhood stroke and porencephaly can only be developed once the causes are understood There is increasing evidence that inherited and acquired coagulation abnormalities alone or in combination with environmental factors predispose to arterial and venous thrombosis Inherited abnormalities of factor V Leiden prothrombin protein C protein S and antithrombin III may account for many of these thromboses At present there is little information on the existing distribution of these coagulation anomalies in children with thrombosis Recent reports also suggest that these clotting abnormalities may be responsible for some instances of intracranial hemorrhage porencephaly cerebral palsy and fetal death
This study will measure the frequency of several coagulation factor abnormalities factor V Leiden prothrombin 20210A protein C protein S antithrombin III and antiphospholipid antibodies in children with a history of porencephaly and stroke and will compare these to the prevalence of these mutations in population controls and family members We will also describe the exogenous conditions which in concert with these coagulation factors may have led to the development of thrombosis in these children
This study will measure the frequency of several coagulation factor abnormalities factor V Leiden prothrombin 20210A protein C protein S antithrombin III and antiphospholipid antibodies in children with a history of porencephaly and stroke and will compare these to the prevalence of these mutations in population controls and family members We will also describe the exogenous conditions which in concert with these coagulation factors may have led to the development of thrombosis in these children
Detailed Description:
OBJECTIVES
Effective treatment and prevention strategies for childhood stroke and porencephaly can only be developed once the causes are understood There is increasing evidence that inherited and acquired coagulation abnormalities alone or in combination with environmental factors predispose to arterial and venous thrombosis Inherited abnormalities of factor V leiden prothrombin protein C protein S and antithrombin III may account for many of these thromboses At present there is little information on the existing distribution of these coagulation anomalies in children with thrombosis Recent reports suggest that these clotting abnormalities may be responsible for some instances of intracranial hemorrhage porencephaly cerebral palsy and fetal death
The objectives of this protocol are 1 to determine the frequency of coagulation abnormalities in children with porencephaly or stroke as compared to healthy children 2 to determine the frequency of coagulation abnormalities in children with porencephaly or stroke as compared to their family members 3 to determine the frequency of coagulation abnormalities in mothers of children with stroke as compared to mothers of healthy children and 4 to describe the exogenous conditions which in concert with coagulation factors may have led to the development of thrombosis in children with stroke
STUDY POPULATION
This study will examine 1 children with a history of porencephaly or stroke 2 their biological mothers fathers and siblings 3 healthy volunteer children and 4 healthy volunteer mothers
DESIGN
This is a case-control study conducted at the National Institute of Neurological Disorders and Stroke Children with a history of porencephaly or stroke before 18 years of life their first-degree relatives healthy volunteer children and healthy volunteer mothers will be enrolled Each subject may complete a blood draw buccal smear questionnaire andor review of medical records depending on their study group
OUTCOME MEASURES
This study will measure the frequency of several coagulation factors among the studys different population groups as well as examine the exogenous conditions that may have contributed to stroke in these children Analysis will be descriptive and quantitative
Effective treatment and prevention strategies for childhood stroke and porencephaly can only be developed once the causes are understood There is increasing evidence that inherited and acquired coagulation abnormalities alone or in combination with environmental factors predispose to arterial and venous thrombosis Inherited abnormalities of factor V leiden prothrombin protein C protein S and antithrombin III may account for many of these thromboses At present there is little information on the existing distribution of these coagulation anomalies in children with thrombosis Recent reports suggest that these clotting abnormalities may be responsible for some instances of intracranial hemorrhage porencephaly cerebral palsy and fetal death
The objectives of this protocol are 1 to determine the frequency of coagulation abnormalities in children with porencephaly or stroke as compared to healthy children 2 to determine the frequency of coagulation abnormalities in children with porencephaly or stroke as compared to their family members 3 to determine the frequency of coagulation abnormalities in mothers of children with stroke as compared to mothers of healthy children and 4 to describe the exogenous conditions which in concert with coagulation factors may have led to the development of thrombosis in children with stroke
STUDY POPULATION
This study will examine 1 children with a history of porencephaly or stroke 2 their biological mothers fathers and siblings 3 healthy volunteer children and 4 healthy volunteer mothers
DESIGN
This is a case-control study conducted at the National Institute of Neurological Disorders and Stroke Children with a history of porencephaly or stroke before 18 years of life their first-degree relatives healthy volunteer children and healthy volunteer mothers will be enrolled Each subject may complete a blood draw buccal smear questionnaire andor review of medical records depending on their study group
OUTCOME MEASURES
This study will measure the frequency of several coagulation factors among the studys different population groups as well as examine the exogenous conditions that may have contributed to stroke in these children Analysis will be descriptive and quantitative
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 |
|---|---|---|---|
| 99-N-0045 | None | None | None |