## Protocol Section
### Identification Module
**NCT ID:** NCT06429787

**Brief 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

**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.

#### Organization Study ID Info
**ID:** LEX-212
#### Organization
**Class:** INDUSTRY
**Full Name:** Octapharma
### Status Module
#### Completion Date
**Date:** 2032-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2031-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Octapharma

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief 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

### Conditions Module

**Conditions:**

- Vitamin K-Dependent Coagulation Defect

- Significant Bleeding Risk

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 3574

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: Balfaxar

**Label:** BALFAXAR® (500 IU)

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Kcentra

**Label:** Kcentra® (500 IU)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BALFAXAR® (500 IU)

**Description:** 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

**Name:** Balfaxar

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Kcentra® (500 IU)

**Description:** 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

**Name:** Kcentra

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** TEEs within 45 days following VKA reversal treatment

**Time Frame:** 45 days

#### Secondary Outcomes

**Description:** 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.

**Measure:** TEEs within 7 and 14 days following VKA reversal treatment

**Time Frame:** 14 days

**Description:** Median time to TEE following administration of BALFAXAR compared to median time to TEE following administration of Kcentra

**Measure:** Median Time to TEEs

**Time Frame:** 45 days

**Description:** 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.

**Measure:** All Cause Mortality

**Time Frame:** 45 days

**Description:** Median time to death following administration of BALFAXAR compared to median time to death following administration of Kcentra

**Measure:** Median Time to All Cause Mortality

**Time Frame:** 45 days

**Description:** 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

**Measure:** Rate of Fatal TEEs

**Time Frame:** 45 days

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** p.murphy@crmg-usa.com

**Name:** Patrick Murphy

**Phone:** 8663371868

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006474

- Term: Hemorrhagic Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: HIGH

- As Found: Coagulation Defect

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: HIGH

- As Found: Coagulation Defect

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020141

- Term: Hemostatic Disorders

- ID: D000001778

- Term: Blood Coagulation Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Coag

- Name: Coagulants

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17602

- Name: Warfarin

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M16676

- Name: Thrombin

- Relevance: LOW

- As Found: Unknown

- ID: M17555

- Name: Vitamin K

- Relevance: LOW

- As Found: Unknown

- ID: T481

- Name: Vitamin K

- Relevance: LOW

- As Found: Unknown

- ID: T449

- Name: Menadione

- Relevance: LOW

- As Found: Unknown

- ID: T450

- Name: Menaquinone

- Relevance: LOW

- As Found: Unknown

- ID: T452

- Name: Naphthoquinone

- Relevance: LOW

- As Found: Unknown

- ID: T458

- Name: Phylloquinone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
