Comparing the safety of two treatments for reversing blood thinning before surgery
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.
This study tests whether two different treatments, Balfaxar and Kcentra, are safe for adults who need urgent surgery after taking blood thinners.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3574 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Octapharma Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06429787 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety of two anticoagulation reversal agents, Balfaxar and Kcentra, in adults who are undergoing urgent surgery or invasive procedures after being treated with vitamin K antagonists. Participants will be monitored for safety outcomes following the administration of these agents within 48 hours prior to their procedures. The study aims to gather real-world data on the effectiveness and safety profiles of these treatments in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are on vitamin K antagonist treatment and require urgent reversal therapy before surgery.
Not a fit: Patients who have had a thromboembolic event within the last 90 days or those not undergoing an urgent invasive procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into safer and more effective management of anticoagulation reversal in patients requiring urgent surgical interventions.
How similar studies have performed: While this study is observational, previous studies have shown varying success with similar anticoagulation reversal agents, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects at least 18 years of age. 2. Subjects on VKA treatment. 3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure. Exclusion Criteria: 1. History of TEE within 90 days before receipt of VKA reversal therapy. 2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
Where this trial is running
Boston, Massachusetts
- Octapharma Research Site — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Patrick Murphy
- Email: p.murphy@crmg-usa.com
- Phone: 8663371868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.