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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: Completed study, sponsored by CSL Behring.
NCT02319460 is a clinical trial that has completed, run by CSL Behring. The registered enrollment target is 2,238 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Interventions
- BIOLOGICAL Plasma
- BIOLOGICAL Kcentra®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,238 participants |
| Start Date | 2014-04-24 |
| Est. Completion | 2020-06-30 |
What the finished NCT02319460 record still lists
NCT02319460 is an observational study that tracks outcomes without assigning an intervention. Its 2,238 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Plasma is the first listed.
NCT02319460 does not publish any study locations in the registry export this page uses.
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.
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