Health TrialsbyHealthPanel

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

ConditionAcquired Antithrombin Deficiency
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorOctapharma

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Human plasma derived antithrombin

    Drug

    A solvent/detergent and heat-treated antithrombin concentrate derived from human plasma

  • Placebo

    Drug

    Half of the patients in the placebo group will be randomised to receive a volume of placebo corresponding to the low dose of Atenativ and the other half to receive a volume of placebo corresponding to a high dose of Atenativ

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Low-dose AtenativExperimental treatment 1 intervention
Group B: High-dose AtenativExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Restoring heparin responsiveness

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

Time frame
During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)

Secondary outcomes

1

Amounts of further therapy for restoring heparin responsiveness

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

Time frame
During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
2

Change in activated clotting time (ACT) values

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

Time frame
Within 5 minutes following intravenous administration of 500 U/kg unfractionated heparin (UFH) and between 2-10 minutes after IMP infusion
3

Change in antithrombin plasma levels

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

Time frame
Within 10 minutes before IMP infusion and between 2 and 10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after the start of IMP infusion
4

Change in heparin usage

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

Time frame
From end of IMP infusion to the end of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Octapharma

Lead sponsor

Source ClinicalTrials.gov
Apply now