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Tests treatment safety and results for Acquired Antithrombin Deficiency
Official title 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
ClinicalTrials.gov ID: NCT06096116
What this study is testing
What is Human plasma derived antithrombin?
Human plasma derived antithrombin is an investigational medicine, being studied as a potential treatment for acquired antithrombin deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Planned cardiac surgery with CPB
- Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration...
- Patients between 18 and 85 years of age, inclusive
- Freely given written or electronic informed consent
- In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery
You likely can't join if
- Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
- vitamin K antagonists (within 3 days)
- direct oral anticoagulants (within 2 days)
- thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory...
- ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
- glycoprotein IIb/IIIa antagonist (within 24 hours)
See the full eligibility criteria
- Planned cardiac surgery with CPB
- Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
- Patients between 18 and 85 years of age, inclusive
- Freely given written or electronic informed consent
- In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery
- Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
- vitamin K antagonists (within 3 days)
- direct oral anticoagulants (within 2 days)
- thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment
- ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
- glycoprotein IIb/IIIa antagonist (within 24 hours)
- Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
- Renal insufficiency, defined as serum creatinine level \>2.0 mg/dL
- Thrombocytosis, defined as platelet count \>400,000 per μL
- Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
- History of anaphylactic reaction(s) to blood or blood components
- Refusal to receive transfusion of blood or blood-derived products
- Current participation in another treatment clinical trial or previous participation in the current trial
- Treatment with any IMP within 30 days prior to screening visit
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Dallas, Texas, United States
- Innsbruck, Austria
- Vienna, Austria
- New Westminster, British Columbia, Canada
- Kingston, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Brno, Czechia
- Prague, Czechia
- Reims, France
- Rennes, France
- Kaunas, Lithuania
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Miami, Florida, United States; Boston, Massachusetts, United States; Durham, North Carolina, United States; Winston-Salem, North Carolina, United States; Cleveland, Ohio, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.