An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding

NCT02319460 | Completed

• 1 other identifier: BE1116_4001
• Study Type: observational
• Target: 2,238
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations. In the setting of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated with plasma will be assessed.

Conditions

Hemorrhage

Keywords

Vitamin K Reversal Antagonist Therapy of Acute Major Bleeding; Warfarin Reversal

Outcome Measures

Primary Outcomes (1)

• Risk of thromboembolic events (TEE) for patients without a recent history of TEE

  The risk of confirmed thromboembolic events (TEE) will be estimated for patients without a recent history of TEE treated with Kcentra® compared to patients treated with plasma. The index date is the date of acute VKA reversal for major bleeding event.

  Within 45 days after the index date

Secondary Outcomes (3)

• Risk of thromboembolic events

  Within 45 days after the index date

• Risk of death from any cause

  Within 45 days after the index date

• Rates of use of VKA therapy after the index date

  Within 90 days after the index date

Study Arms (2)

Retrospective

Retrospective cohort of adults hospitalized for major bleeding during 2008 to 2013 who receive plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy

Biological: Plasma

Prospective

Prospective parallel cohort of adults hospitalized for major bleeding during 2014 to 2020 who either receive Kcentra® or plasma for urgent reversal of acquired coagulation factor deficiency induced by oral VKA therapy

Biological: Kcentra®; Biological: Plasma

Interventions

Kcentra® BIOLOGICAL

Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product that contains coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S as a lyophilized concentrate.

Also known as: Prothrombin Complex Concentrate (Human), Beriplex

Prospective

Plasma BIOLOGICAL

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult members of the Kaiser Permanente Northern and Southern California health care delivery systems, receiving chronic warfarin therapy and meeting study eligibility criteria.

You may qualify if:

• Aged 18 years and older at admission for VKA-associated major bleeding
• A minimum of 365 days of continuous health plan enrollment before the index hospitalization involving acute VKA reversal treatment
• A minimum of 365 days of continuous pharmacy benefit before the index hospitalization involving acute VKA reversal treatment

You may not qualify if:

• Patients will be excluded from the primary analyses if they:
• Require urgent reversal of VKA therapy in the setting of bleeding due to major trauma (eg, motor vehicle accident)
• Requiring urgent reversal of VKA therapy for a surgical procedure unrelated to major bleeding (eg, appendicitis)

Sponsors & Collaborators

• CSL Behring: lead
• Kaiser Permanente: collaborator

Study Sites (1)

Study Site

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Factor IX; factor IX, factor VII, factor X, prothrombin drug combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Clinical Epidemiologist

  CSL Behring

  STUDY DIRECTOR

• Alan S. Go, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Kristi Reynolds, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: April 24, 2014
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

US (1)