Status and phase
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About
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)
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
Pre-existing coagulopathy, a history of bleeding problems, 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 >1.5 mg/dL
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 interventional clinical trial or previous participation in the current trial
Treatment with any IMP within 30 days prior to screening visit
Primary purpose
Allocation
Interventional model
Masking
120 participants in 3 patient groups, including a placebo group
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Central trial contact
Sigurd Knaub, PhD
Data sourced from clinicaltrials.gov
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