Vitamin K-Dependent Coagulation DefectNCT06429787
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
An observational study of Vitamin K-Dependent Coagulation Defect and Significant Bleeding Risk, run by Octapharma at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
- What is being tested?
- Balfaxar and Kcentra
- Type of treatment
- Injection or infusion
- How many people
- 3,574 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 30 Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at least 18 years of age who are currently on Vitamin K Antagonist treatments and received BALFAXAR or Kcentra for urgent reversal of VKA therapy within 48 hours prior to urgent surgery or invasive procedure. Octapharma will not actively enroll any of the 3,574 projected subjects into the study. Subjects meeting the minimum inclusion and exclusion criteria during the course of routine practice will be added to the study on a monthly basis until the sample size required for the analysis is achieved in each group.
Who may be able to join
- Subjects at least 18 years of age.
- Subjects on VKA treatment.
- Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.
Who cannot join
- History of TEE within 90 days before receipt of VKA reversal therapy.
- Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Octapharma Research Site
Boston, Massachusetts, 02215
About this study
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.
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
- Being tested
- Balfaxar, Kcentra
- Medical subject headings
- Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalfaxarDrug
BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure
KcentraDrug
KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:
- acute major bleeding or
- need for an urgent surgery/invasive procedure
| Study group | Role | What they receive |
|---|---|---|
| BALFAXAR® (500 IU) | BALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight Receives: Drug: Balfaxar | |
| Kcentra® (500 IU) | KCENTRA will be administered by intravenous infusion at of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight. Receives: Drug: Kcentra |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEEs within 45 days following VKA reversal treatment
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.
Measured: 45 days
Secondary outcomes (5)
TEEs within 7 and 14 days following VKA reversal treatment
Proportion of subjects diagnosed with TEEs within 7 and 14 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.
Measured: 14 days
Median Time to TEEs
Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra
Measured: 45 days
All Cause Mortality
Proportion of subjects who die from any reason within 7, 14 and 45 days following VKA reversal treatment with BALFAXAR compared to proportion of subjects who die from any reason within the same time period following treatment with Kcentra.
Measured: 45 days
Median Time to All Cause Mortality
Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra
Measured: 45 days
Rate of Fatal TEEs
Rate of fatal TEEs following treatment with BALFAXAR compared to rate of fatal TEEs following treatment with Kcentra within 7, 14 and 45 days following VKA reversal treatment
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start14 Feb 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin K-Dependent Coagulation DefectStudies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,574 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429787
- Sponsor's protocol ID
- LEX-212
- Status last verified
- Aug 2026
- First submitted
- 21 May 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06429787
- Acronym / sponsor ID
- LEX-212
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,574 participants (estimated)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BALFAXAR® (500 IU) | – | Drug: BalfaxarBALFAXAR will be administered by intravenous (IV) infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight |
| Kcentra® (500 IU) | – | Drug: KcentraKCENTRA will be administered by intravenous infusion at of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min). Dosing is individualized based on the patient's baseline International Normalized Ratio (INR) value and body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at least 18 years of age who are currently on Vitamin K Antagonist treatments and received BALFAXAR or Kcentra for urgent reversal of VKA therapy within 48 hours prior to urgent surgery or invasive procedure. Octapharma will not actively enroll any of the 3,574 projected subjects into the study. Subjects meeting the minimum inclusion and exclusion criteria during the course of routine practice will be added to the study on a monthly basis until the sample size required for the analysis is achieved in each group.
Key inclusion criteria (3 listed)
- Subjects at least 18 years of age.
- Subjects on VKA treatment.
- Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.
Key exclusion criteria (2 listed)
- History of TEE within 90 days before receipt of VKA reversal therapy.
- Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BalfaxarBALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure | Drug | BALFAXAR® (500 IU) |
| KcentraKCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: * acute major bleeding or * need for an urgent surgery/invasive procedure | Drug | Kcentra® (500 IU) |
Primary outcome
TEEs within 45 days following VKA reversal treatment
Time frame: 45 days
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.
5 secondary outcomes
TEEs within 7 and 14 days following VKA reversal treatment
Time frame: 14 days
Median Time to TEEs
Time frame: 45 days
All Cause Mortality
Time frame: 45 days
Median Time to All Cause Mortality
Time frame: 45 days
Rate of Fatal TEEs
Time frame: 45 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin K-Dependent Coagulation Defect and Significant Bleeding Risk, run by Octapharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEEs within 45 days following VKA reversal treatment (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.