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Home > "S" Clinical Trials Conditions > Study of Abnormal Blood Clotting in Children with Stroke  Study of Abnormal Blood Clotting in Children with Stroke
Study of Abnormal Blood Clotting in Children with Stroke
For Condition: Abnormalities,Blood Coagulation Disorder,Brain Disease,Cerebrovascular Accident,Vascular Disease
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: A stroke is a sudden neurological condition caused by an abnormality in blood flow to the brain. Studies on strokes in children estimate that 2.5 out of 100,000 children will suffer a stroke. Pediatric strokes occur more frequently in children less than 2 years old. The causes of strokes in children are often undetermined. Effective treatment and prevention plans for childhood strokes can only be developed once the causes are understood. There is increasing evidence that blood-clotting abnormalities alone or in combination with environmental factors may be responsible for blood clots in arteries and veins. There are many compounds that play a role in the normal pathway of blood clotting in the body. Abnormalities in any one of these compounds can account for the development of stroke-causing blood clots. Presently, there is very little information on these abnormalities in children. This study is designed to measure the frequency of several specific blood-clotting abnormalities in children with a history of stroke and porencephaly (pockets/cavities within the brain). Data collected from this study will be compared to statistics of these conditions in the rest of the population.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: The study population will consist of patients, with a diagnosis or porencephaly and or stroke, recruited from Children's Memorial Hospital and the outside community. PATIENT POPULATION: (Cases) Children less than 18 years of age with a history of porencephaly and or cerebral infarction (stroke). Children less than 18 years of age with a history of spastic hemiplegic or quadriplegic cerebral palsy with radiographic evidence of stroke or porencephaly. A diagnosis of porencephaly as defined by a fluid-filled cavity within the cerebral hemispheres which may or may not communicate with CSF spaces and confirmed by at least one imaging method including computed tomography (CT), magnetic resonance (MR) and or Doppler ultrasonography. A diagnosis of cerebral infarction (stroke) as defined by a new focal neurologic deficit lasting greater than or equal to 24 hours and presumably due to a vascular process and confirmed by brain imaging, either computed tomography (CT), magnetic resonance (MR) or Doppler ultrasonography. Informed consent of the parent. Informed assent of the child when available. NORMAL VOLUNTEERS (CHILDREN): Informed consent of the parent. Informed assent of the child when available. PARENTS AND SIBLINGS OF CHILDRFEN WITH STROKE: Informed consent of each participant. Informed assent of each participant under 18 years, when available. MOTHERS OF CHILDREN WITH STROKE: Informed consent of the mother. NORMAL VOLUNTEERS (MOTHERS): Informed consent of the volunteer. Volunteers between 18 and 45 years of age. History of full-term pregnancy. EXCLUSION CRITERIA: PATIENT POPULATION: (Cases) Children greater than 18 years of age. Maternal history of cocaine abuse during pregnancy. History of cancer. History of other chromosomal or metabolic disorder. History of trauma and or child abuse. Isolated subdural hematomas. History of aneurysm or vascular malformations. Congenital heart disease. Sickle cell disease. History of CNS infection. NORMAL VOLUNTEERS (CHILDREN): Children greater than 18 years of age. Maternal history of cocaine abuse during pregnancy. History of cancer. History of other chromosomal or metabolic disorder. History of trauma and or child abuse. Isolated subdural hematomas. History of aneurysm or vascular malformations. Congenital heart disease. Sickle cell disease. History of CNS infection. History of stroke or porencephaly. NORMAL VOLUNTEERS (MOTHERS): Volunteer has biological children with a history of cancer, head trauma, aneurysm, chromosomal or metabolic disorder, congenital heart disease, sickle cell disease, meningitis or encephalitis, or stroke. Cocaine use during pregnancy.
Total Enrollment: 1046
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 990045; 99-N-0045
Study Start Date: February 22, 1999
Record last reviewed: February 25, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001927
Other Blood Coagulation Disorder Studies:
1. Study of Abnormal Blood Clotting in Children with Stroke
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Study of Abnormal Blood Clotting in Children with Stroke
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