Status:
COMPLETED
Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Newton-Wellesley Hospital
Conditions:
Pulmonary Embolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this research study, the investigators are trying to find a better way to set the dose of a common blood-thinning medication. Patients with blood clots or a risk of blood clots (or stroke) sometim...
Detailed Description
This is Phase 1 of a 3-phase plan in which we will ultimately test whether rapid turnaround genetic testing can improve the safety and efficacy of warfarin anticoagulation in warfarin naïve patients w...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Any newly diagnosed condition that will require treatment with therapeutic doses of warfarin for at least 4-6 weeks, e.g. deep venous thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation (AF), orthopedic surgery, etc.
- Written informed consent
Exclusion
- Current treatment with warfarin
- Contraindication to therapeutic anticoagulation:
- Active major bleeding
- History of intracranial bleeding
- Surgery, delivery, organ biopsy within 3 days
- Gastrointestinal bleeding within 10 days
- Major trauma within 3 days
- Head injury requiring hospitalization within 3 months
- Intracranial tumor
- Neurosurgery or ophthalmologic surgery within the past month
- Life expectancy \< 3 months
- Pregnancy
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00401414
Start Date
January 1 2007
End Date
June 1 2011
Last Update
August 30 2013
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115