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Trial record 70 of 291 for:    warfarin AND anticoagulation

Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC) (KVAD)

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ClinicalTrials.gov Identifier: NCT03473132
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Jean M Connors, Brigham and Women's Hospital

Brief Summary:
Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).

Condition or disease Intervention/treatment Phase
Anticoagulation Anticoagulation Reversal Drug: four factor prothrombin complex concentrate Phase 4

Detailed Description:
Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study of consecutive patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal With 4F-PCC
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: 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.
Drug: 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.




Primary Outcome Measures :
  1. plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio [ Time Frame: through 48 hours ]
    assessment of change in vitamin K dependent coagulation factor levels after infusion of 4F-PCC


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 30 days ]
    bleeding

  2. adverse events [ Time Frame: 30 days ]
    thrombosis



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria:

  • recent thrombotic event

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473132


Contacts
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Contact: Jean M Connors, MD 617-525-9337 jconnors@bwh.harvard.edu
Contact: Revital Freedman, PhD 617-525-9337 rfreedman5@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Brooke Fortin, BA    617-525-9337    bfortin@bwh.harvard.edu   
Contact: Revital Freedman, PhD    617-525-9337    rfreedman5@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
CSL Behring
Investigators
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Principal Investigator: Jean M Connors, MD Brigham and Women';s Hospital

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Responsible Party: Jean M Connors, Director, Hemostatic and Antithrombotic Stewardship Program, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03473132     History of Changes
Other Study ID Numbers: 2017P001254
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warfarin
Thrombin
Anticoagulants
Hemostatics
Coagulants