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NCT02319460 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by CSL Behring.

Completed
Registry status
2,238
Enrollment target

NCT02319460 is a clinical trial that has completed, run by CSL Behring. The registered enrollment target is 2,238 participants.

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The verdict

NCT02319460 has completed, sponsored by CSL Behring.

COMPLETED
Registry status
2,238 participants
Enrollment target

Study 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.

Interventions

  • BIOLOGICAL Plasma
  • BIOLOGICAL Kcentra®

Trial Details

FieldValue
Enrollment Target 2,238 participants
Start Date 2014-04-24
Est. Completion 2020-06-30

Sponsor

CSL Behring

71 total trials

What the Registry Record Tells You About NCT02319460

The ClinicalTrials.gov registry entry for NCT02319460 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2,238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Plasma is the first listed.

NCT02319460 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02319460 about?

NCT02319460 is a clinical study titled "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". 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 ev...

What is the current status of trial NCT02319460?

This trial is currently completed. The enrollment target is 2,238 participants. The study started on 2014-04-24. Estimated completion is 2020-06-30.

What interventions are being tested in trial NCT02319460?

The interventions under investigation include: Plasma (BIOLOGICAL), Kcentra® (BIOLOGICAL).

Who is sponsoring clinical trial NCT02319460?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.