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 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

Acquired Antithrombin Deficiency

Human plasma derived antithrombin

Placebo

Phase 3, Double-blind, Placebo-controlled, Multicentre 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 percentage of patients in each group in whom no further therapy containing
antithrombin (i.e. frozen plasma or other antithrombin concentrates) is needed for
restoring pre-CPB heparin responsiveness after administration of Atenativ or placebo, and
for maintaining it during CPB

The comparison between the amounts of further therapy containing antithrombin (i.e., FP
or antithrombin concentrates) needed for restoring pre-CPB heparin responsiveness, after
administration of Atenativ or placebo, and for maintaining it during CPB

The comparison between the change in ACT values following infusion of each of the
Atenativ doses and placebo

The comparison between the change in antithrombin plasma levels following infusion of
each of the Atenativ doses and placebo

The comparison between heparin usage following the infusion of each of the Atenativ doses
and infusion of placebo

The comparison between the number of units of FP transfused for reasons other than
restoring or maintaining heparin responsiveness, both intraoperatively (from the start of
Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB
until the end of surgery) and postoperatively (from the end of surgery until 24 hours
after the start of Atenativ or placebo infusion and until discharge or 7 days after
surgery, whichever comes first), as well as cumulatively

The comparison between postoperative use of antithrombin concentrates for reasons other
than restoring heparin responsiveness (from the end of surgery until 24 hours after the
start of Atenativ or placebo infusion and until discharge or 7 days after surgery,
whichever comes first)

The comparison between transfusion of other allogeneic blood products (e.g., red blood
cells [RBCs], platelets, cryoprecipitate), both intraoperatively (from the start of
Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB
until the end of surgery) and postoperatively (from the end of surgery until 24 hours
after the start of Atenativ or placebo infusion and until discharge or 7 days after
surgery, whichever comes first), as well as cumulatively

The comparison between administration of coagulation factor concentrates such as
fibrinogen concentrate, prothrombin complex concentrate (PCC), factor XIII concentrate
and recombinant activated factor VII, both intraoperatively (from the start of Atenativ
or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the
end of surgery) and postoperatively (from the end of surgery until 24 hours after the
start of Atenativ or placebo infusion and until discharge or 7 days after surgery,
whichever comes first), as well as cumulatively

The comparison between administration of other haemostatic-relevant therapies (e.g.,
tranexamic acid, protamine), both intraoperatively (from the start of Atenativ or placebo
infusion until the start of CPB, during CPB, and from the end of CPB until the end of
surgery) and postoperatively (from the end of surgery until 24 hours after the start of
Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes
first), as well as cumulatively

The comparison between postoperative chest tube drainage volume at 24 hours after the
start of Atenativ or placebo infusion, and the comparison between total chest tube
drainage volume until discharge or 7 days after surgery, whichever comes first

Comparison of the need for reoperation for bleeding, including description of the cause
of bleeding (surgical vs. non-surgical)

The comparison between cell saver volume until the end of surgery

Incidence of adverse events, including all related and non-related, non-serious adverse
events

Number of patients surviving in all three cohorts

Patients will receive a saline bolus dose

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?