RECRUITING

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Official Title

Post Marketing Observational Study on Safety of BALFAXAR® vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure.

Quick Facts

Study Start:2025-01-30
Study Completion:2032-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06429787

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects at least 18 years of age.
  2. 2. Subjects on VKA treatment.
  3. 3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.
  1. 1. History of TEE within 90 days before receipt of VKA reversal therapy.
  2. 2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.

Contacts and Locations

Study Contact

Patrick Murphy
CONTACT
8663371868
p.murphy@crmg-usa.com

Study Locations (Sites)

Octapharma Research Site
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Octapharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30
Study Completion Date2032-06-30

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2032-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Vitamin K-Dependent Coagulation Defect
  • Significant Bleeding Risk