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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Page 1 of 1 (2 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115