Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
Public ClinicalTrials.gov record NCT00618098. 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
A Randomized, Open-label, Efficacy and Safety Study of Octaplex and Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures
Study identification
- NCT ID
- NCT00618098
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Octapharma
- Industry
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- Octaplex (human prothrombin complex concentrate) Biological
- Fresh frozen plasma Biological
Biological
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
- Apr 30, 2008
- Primary completion
- Feb 29, 2012
- Completion
- Jul 31, 2012
- Last update posted
- Jan 30, 2023
2008 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Contact Octapharma for Facility details | Philadelphia | Pennsylvania | 19141 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00618098, 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 Jan 30, 2023 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00618098 live on ClinicalTrials.gov.