Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)
NCT ID: NCT03473132
Last Updated: 2021-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2018-03-15
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Based on starting international normalized ratio (INR) and target INR, the dose of four factor prothrombin complex concentrate will be calculated and infused. Coagulation factor levels will be assessed over 48-72 hours.
four factor prothrombin complex concentrate
After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.
Interventions
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four factor prothrombin complex concentrate
After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Brigham and Women's Hospital
OTHER
Responsible Party
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Jean M Connors
Director, Hemostatic and Antithrombotic Stewardship Program
Principal Investigators
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Jean M Connors, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women';s Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017P001254
Identifier Type: -
Identifier Source: org_study_id
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