Trials / Completed
CompletedNCT02319460
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
An Observational Cohort Study of the Risk of Thromboembolic Events Among Adult Patients Treated With KCENTRA® Compared With Plasma for Urgent Reversal of Vitamin K Antagonist Therapy in the Setting of Acute Major Bleeding
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,238 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Kcentra® | 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. |
| BIOLOGICAL | Plasma |
Timeline
- Start date
- 2014-04-24
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
- First posted
- 2014-12-18
- Last updated
- 2021-05-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02319460. Inclusion in this directory is not an endorsement.