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NCT06429787 · ClinicalTrials.gov registry record
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
A clinical trial of Vitamin K-Dependent Coagulation Defect and Significant Bleeding Risk, sponsored by Octapharma.
- Recruiting
- Registry status
- 3,574
- Enrollment target
- 1
- Study location
NCT06429787: Recruiting study of Vitamin K-Dependent Coagulation Defect and Significant Bleeding Risk, sponsored by Octapharma.
NCT06429787 is a study of Vitamin K-Dependent Coagulation Defect and Significant Bleeding Risk that is actively recruiting participants, run by Octapharma. The registered enrollment target is 3,574 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06429787, a study of Vitamin K-Dependent Coagulation Defect and Significant Bleeding Risk, is actively recruiting participants, sponsored by Octapharma.
- RECRUITING
- Registry status
- 3,574 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Proportion of subjects diagnosed with TEEs within 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects diagnosed with TEEs within the same period following VKA reversal treatment with Kcentra.
Conditions Studied
Interventions
- DRUG Balfaxar
- DRUG Kcentra
Study Locations (1)
Massachusetts
- Octapharma Research Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,574 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2032-06-30 |
What NCT06429787 shows while recruiting
NCT06429787 is an observational study that tracks outcomes without assigning an intervention. Its 3,574 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with Vitamin K-Dependent Coagulation Defect appearing as the primary indexed condition, and to 2 interventions - of which Balfaxar is the first listed.
NCT06429787 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06429787 about?
NCT06429787 is a clinical study titled "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". 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
What is the current status of trial NCT06429787?
This trial is currently recruiting. The enrollment target is 3,574 participants. The study started on 2025-02-14. Estimated completion is 2032-06-30.
What conditions does trial NCT06429787 study?
This clinical trial studies the following conditions: Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk.
What interventions are being tested in trial NCT06429787?
The interventions under investigation include: Balfaxar (DRUG), Kcentra (DRUG).
Who is sponsoring clinical trial NCT06429787?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06429787 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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