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Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia
NCT01158807 · View on ClinicalTrials.gov ↗
Study Summary
This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium. A "consortium" is a group of centres sharing information and resources to perform research. The consortium research focuses on brain blood vessel malformations in three different rare diseases. The focus of this specific study is on Hemorrhagic Telangiectasia (HHT). HHT is a condition characterized by blood vessel malformations, called telangiectasia and arteriovenous malformations (AVMs), occurring in the brain, nose, lungs, stomach, bowels and liver. Brain AVMs (BAVMs) in HHT are difficult to study because they are rare, affecting approximately 10% of people with HHT. While other types of BAVMs have been studied in depth, studies in the HHT population have been very small. Here, we propose the first large-scale collaboration by joining with 12 HHT Centers of Excellence in North America to perform a large study of risk factors for bleeding from BAVMs, called intracranial hemorrhage (ICH) in HHT patients. The current standard of clinical practice across North America, is to screen all HHT patients for BAVMs with magnetic resonance imaging (MRI). If BAVMs are detected, patients are referred to a multidisciplinary neurovascular team for consideration for treatment. Treatment decisions are made on a case by case basis, balancing risks of complications from the BAVM with risks of therapy, but are limited by the few studies available in HHT. We hope that the knowledge we obtain about the risk factors for intracranial bleeding in these patients from this larger study will help us to improve the care of HHT patients. We plan to study risk factors for rupture of BAVMs, including primarily genetics and imaging characteristics of the BAVMs. Knowledge about risk factors will help in the care and management of HHT patients. This will be achieved through the collection of health information to construct a HHT database, blood sampling and banking (through the National Institute of Neu
Conditions Studied
Study Locations (19)
California
- David Geffen School of Medicine at University of California, Los Angeles — Los Angeles
- University of California, San Francisco — San Francisco
Maryland
- Johns Hopkins University School of Medicine — Baltimore
- HHT Foundation International, Inc. — Monkton
Ontario
- St. Michael's Hospital — Toronto
- Hospital for Sick Children — Toronto
Arizona
- Barrow Neurological Institute — Phoenix
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
Colorado
- UCHealth Pulmonary Vascular Disease Clinic - Anschutz Medical — Aurora
Connecticut
- Yale University — New Haven
Georgia
- Georgia Regents University — Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,272 participants |
| Start Date | 2010-04-08 |
| Est. Completion | 2025-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01158807
The ClinicalTrials.gov registry entry for NCT01158807 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Unity Health Toronto, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hereditary Hemorrhagic Telangiectasia appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01158807 reports 19 study locations spanning 16 distinct geographic areas — top geographies include California, Maryland, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01158807 about?
NCT01158807 is a clinical study titled "Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia". This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium. A "consortium" is a group of centres sharing information and resources to perform research. The consortium research focuses on brain blood vessel malformations in three different rare diseases. The focus of...
What is the current status of trial NCT01158807?
This trial is currently active not recruiting. The enrollment target is 2,272 participants. The study started on 2010-04-08. Estimated completion is 2025-06-30.
What conditions does trial NCT01158807 study?
This clinical trial studies the following conditions: Hereditary Hemorrhagic Telangiectasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01158807?
This trial is sponsored by Unity Health Toronto, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01158807 being conducted?
This trial has 19 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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