AbnormalitiesNCT00001927
Study of Abnormal Blood Clotting in Children With Stroke
An observational study of Abnormalities and Blood Coagulation Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Abnormalities, Blood Coagulation Disorder, Brain Disease
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 1999to 4 May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CHILDREN WITH A HISTORY OF PORENCEPHALY OR STROKE:
- Children less than 18 years of age with a history of porencephaly or cerebral infarction (stroke).
- Children less than 18 years of age with a history of spastic hemiplegic or quadriplegic cerebral palsy (ICD-9 codes 343.1, 343.2, 343.3, 343.4, 343.8 and 343.9) with radiographic evidence of porencephaly or stroke.
- 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 (ICD-9 codes 430-437) and confirmed by brain imaging, either computed tomography (CT), magnetic resonance (MR) or Doppler ultrasonography.
- Informed consent of the parent.
Show all 19Show fewer
- Informed assent of the child, when available.
- FIRST-DEGREE RELATIVES OF CHILDREN WITH PORENCEPHALY OR STROKE:
- Full biological first-degree relatives of children with a history of porencephaly or stroke enrolled in this study.
- Informed consent of each participant.
- Informed assent of each participant under 18 years, when available.
- HEALTHY CHILDREN:
- Children less than 18 years of age.
- Informed consent of the parent.
- Informed assent of the child when available.
- HEALTHY MOTHERS:
- Women between 18 and 45 years of age.
- History of full-term pregnancy.
- Informed consent of the participant.
Who cannot join
- CHILDREN WITH A HISTORY OF PORENCEPHALY OR STROKE:
- 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.
Show all 26Show fewer
- Isolated subdural hematomas.
- History of aneurysm or vascular malformations.
- Congenital heart disease.
- Sickle cell disease.
- History of CNS infection.
- HEALTHY 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.
- HEALTHY MOTHERS:
- Volunteer has biological children without 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Study of Abnormal Acquired and Genetic Coagulation Factors in Children With Porencephaly and Stroke
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....
Read the 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, and/or review of medical records depending on their study group.
OUTCOME MEASURES:
This study will measure the frequency of several coagulation factors among the study's 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.
- Conditions
- Abnormalities, Blood Coagulation Disorder, Brain Disease, Cerebrovascular Accident, Vascular Disease
- Keywords
- Factor V Leiden, Prothrombin Mutation, Antiphospholipids, Cerebral Infarction, Thrombophilia, Porencephaly, Perinatal Stroke, Healthy Mothers, Healthy Children
- Medical subject headings
- Congenital Abnormalities, Blood Coagulation Disorders, Brain Diseases, Stroke, Vascular Diseases, Cerebral Infarction, Thrombophilia, Porencephaly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start22 Feb 1999
- Study completion4 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AbnormalitiesStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001927
- Sponsor's protocol ID
- 990045
- Other IDs
- 99-N-0045
- Status last verified
- 4 May 2011
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Griffin JH, Evatt B, Zimmerman TS, Kleiss AJ, Wideman C. Deficiency of protein C in congenital thrombotic disease. J Clin Invest. 1981 Nov;68(5):1370-3. doi: 10.1172/jci110385.
PubMed 6895379Allaart CF, Poort SR, Rosendaal FR, Reitsma PH, Bertina RM, Briet E. Increased risk of venous thrombosis in carriers of hereditary protein C deficiency defect. Lancet. 1993 Jan 16;341(8838):134-8. doi: 10.1016/0140-6736(93)90003-y.
PubMed 8093743Poort SR, Rosendaal FR, Reitsma PH, Bertina RM. A common genetic variation in the 3'-untranslated region of the prothrombin gene is associated with elevated plasma prothrombin levels and an increase in venous thrombosis. Blood. 1996 Nov 15;88(10):3698-703.
PubMed 8916933
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Abnormal Acquired and Genetic Coagulation Factors in Children With Porencephaly and Stroke
- ClinicalTrials.gov ID
- NCT00001927
- Acronym / sponsor ID
- 990045
- Conditions
- Abnormalities, Blood Coagulation Disorder, Brain Disease, Cerebrovascular Accident, Vascular Disease
- Keywords
- Factor V Leiden, Prothrombin Mutation, Antiphospholipids, Cerebral Infarction, Thrombophilia, Porencephaly, Perinatal Stroke, Healthy Mothers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 22 Feb 1999
- Study completion
- 4 May 2011
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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, and/or review of medical records depending on their study group.
OUTCOME MEASURES:
This study will measure the frequency of several coagulation factors among the study's 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 design
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Children less than 18 years of age with a history of porencephaly or cerebral infarction (stroke).
- Children less than 18 years of age with a history of spastic hemiplegic or quadriplegic cerebral palsy (ICD-9 codes 343.1, 343.2, 343.3, 343.4, 343.8 and 343.9) with radiographic evidence of porencephaly or stroke.
- 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 (ICD-9 codes 430-437) and confirmed by brain imaging, either computed tomography (CT), magnetic resonance (MR) or Doppler ultrasonography.
- Informed consent of the parent.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 6895379Griffin JH, Evatt B, Zimmerman TS, Kleiss AJ, Wideman C. Deficiency of protein C in congenital thrombotic disease. J Clin Invest. 1981 Nov;68(5):1370-3. doi: 10.1172/jci110385.
- Background: PubMed 8093743Allaart CF, Poort SR, Rosendaal FR, Reitsma PH, Bertina RM, Briet E. Increased risk of venous thrombosis in carriers of hereditary protein C deficiency defect. Lancet. 1993 Jan 16;341(8838):134-8. doi: 10.1016/0140-6736(93)90003-y.
- Background: PubMed 8916933Poort SR, Rosendaal FR, Reitsma PH, Bertina RM. A common genetic variation in the 3'-untranslated region of the prothrombin gene is associated with elevated plasma prothrombin levels and an increase in venous thrombosis. Blood. 1996 Nov 15;88(10):3698-703.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormalities and Blood Coagulation Disorder, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001927, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.