An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
Public ClinicalTrials.gov record NCT00803101. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.
Study identification
- NCT ID
- NCT00803101
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 176 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2009 (Type not available)
- Primary completion
- Nov 2012 (Actual)
- Completion
- Feb 2013 (Actual)
- Last update posted
- Apr 6, 2015
2009 – 2013
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | Newark | Delaware | 19718 | — |
| Study site | Lexington | Kentucky | 40536 | — |
| Study Site | Boston | Massachusetts | 02114 | — |
| Study Site | Duluth | Minnesota | 55805 | — |
| Study Site | Minneapolis | Minnesota | 55415 | — |
| Study Site | Albuquerque | New Mexico | 87131 | — |
| Study Site | Rochester | New York | 14642 | — |
| Study Site | Winston-Salem | North Carolina | 27157 | — |
| Study Site | Philadelphia | Pennsylvania | 19107 | — |
| Study Site | West Reading | Pennsylvania | 19611 | — |
| Study Site | Wilkes-Barre | Pennsylvania | 18711 | — |
| Study Site | Memphis | Tennessee | 38163 | — |
| Study Site | Austin | Texas | 78701 | — |
| Study site | Bryan | Texas | 77802 | — |
| Study Site | El Paso | Texas | 79905 | — |
| Study Site | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00803101, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 6, 2015 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00803101 live on ClinicalTrials.gov.