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

Significant Bleeding Risk Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429787
• Other study ID #: LEX-212
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: June 30, 2032

Study information

• Verified date: May 2024
• Source: Octapharma
• Contact: Patrick Murphy
• Phone: 8663371868
• Email: p.murphy[@]crmg-usa.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3574
• Est. completion date: June 30, 2032
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Significant Bleeding Risk

Intervention

Drug:
• Balfaxar
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
• Kcentra
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 days
Secondary	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.	14 days
Secondary	Median Time to TEEs	Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra	45 days
Secondary	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.	45 days
Secondary	Median Time to All Cause Mortality	Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra	45 days
Secondary	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	45 days