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Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
NCT06096116 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Human plasma derived antithrombin
Study Locations (20)
Other
- University Hospital Innsbruck — Innsbruck
- Vienna General Hospital AKH, Medical University of Vienna — Vienna
- Center of Cardiovascular and Transplant Surgery — Brno
- Institute for Clinical and Experimental Medicine — Prague
- CHU de Reims, Hôpital Robert Debré — Reims
- CHU de Rennes — Rennes
- Hospital of Lithuanian university of Health sciences Kauno Klinikos — Kaunas
- Institute for Cardiovascular Diseases C.C. Iliescu — Bucharest
North Carolina
- Duke University Medical Center — Durham
- Atrium Health Wake Forest Baptist — Winston-Salem
Ontario
- Kingston Health Sciences Centre — Kingston
- Toronto General Hospital — Toronto
California
- Stanford University School of Medicine — Stanford
Florida
- University of Miami — Miami
Massachusetts
- Massachusetts General Hospital — Boston
Ohio
- The Ohio State University — Columbus
Oklahoma
- OU Health University of Oklahoma Medical Center — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-08-21 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06096116
The ClinicalTrials.gov registry entry for NCT06096116 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acquired Antithrombin Deficiency appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06096116 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, North Carolina, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06096116 about?
NCT06096116 is a clinical study titled "Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass". The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
What is the current status of trial NCT06096116?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2024-08-21. Estimated completion is 2028-03.
What conditions does trial NCT06096116 study?
This clinical trial studies the following conditions: Acquired Antithrombin Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06096116?
The interventions under investigation include: Placebo (DRUG), Human plasma derived antithrombin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06096116?
This trial is sponsored by Octapharma, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06096116 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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