Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
Public ClinicalTrials.gov record NCT04867837. 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
Study of Four-factor Prothrombin Complex Concentrate, OCTAPLEX, in Patients With Acute Major Bleeding on Direct Oral Anticoagulant (DOAC) Therapy With Factor Xa Inhibitor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.
Study identification
- NCT ID
- NCT04867837
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 100 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
- Sep 1, 2021 (Actual)
- Primary completion
- Jan 13, 2026 (Actual)
- Completion
- Jan 13, 2026 (Actual)
- Last update posted
- Jun 25, 2026
2021 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harbor-UCLA Medical Center | Torrance | California | 90509 | — |
| The University of Florida | Gainesville | Florida | 32610 | — |
| St. Mary's Medical Center | West Palm Beach | Florida | 33407 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| OU Health - University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Ascension Seton Medical Center Austin | Austin | Texas | 78712 | — |
| Dell Seton Medical Center at the University of Texas | Austin | Texas | 78712 | — |
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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04867837, 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 Jun 25, 2026 · Synced Oct 17, 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 NCT04867837 live on ClinicalTrials.gov.