Complex cardiovascular surgery with cardiopulmonary bypass Cardiopulmonary bypass
Conditions
Interventions
A single dose of BE1116 or FPP will be administered by intravenous infusion intraoperatively.
Sponsors
Akama Hideto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult greater than or equal to (>=) 18 years and has providedwritten informed consent. 2. Undergoing elective complex cardiovascular surgery requiring cardiopulmonary bypass, including procedures of the thoracic aorta (with or without additionalcardiac interventions), aortic valve replacement + coronary arterybypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are asfollows: heart transplantation, insertion or removal of ventricularassist devices (except for intra-aortic balloon pumps), and acuterepair of thoracoabdominal aneurysms. 3. Coagulation factor replacement (ie, 4-Factor prothrombin complex concentrate [4F-PCC] or fresh frozen plasma [FFP]) is ordered inthe operating room for the management of bleeding, in accordancewith accepted clinical standards. The following criteria must be met: - International normalized ratio (INR) >= 1.6 (point-of-care INR testing by Hemochron at least 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility. - Significant microvascular hemorrhage (ie, not due to surgicalcomplications), as defined by a Bleeding Severity Scale (BSS) score of >= 2.
Exclusion criteria
Exclusion criteria: Administration of any systemic hemostatic therapy, such ascryoprecipitate, platelets, FFP, PCC (eg, 4F-PCC / 3F-PCC), Factor VIII (FVIII) inhibitor bypassing activity(FEIBA), recombinant activated Factor VIIa (rFVIIa), or othercoagulation factor products, in the 24 hours before study surgery,except when FFP is added to the cardiopulmonary bypass circuit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful correction (yes vs no) of coagulation factor deficiency as measured by an INR of <= 1.4 at 30 minutes after the end of investigational product (IP) infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Hemostatic response (effective vs not effective) from 30 minutes to 24 hours after the end of IP infusion. 2 Successful correction (yes vs no) of coagulation factor deficiency as measured by a rotational thromboelastometry (ROTEM) extrinsically activated thromboelastometric test (EXTEM) clotting time (CT)<= 80 seconds or thromboelastography (TEG) reaction time <= 8 minutes at 30 minutes after the end of IP infusion. 3 Change in INR from baseline to 30 minutes, and 6, 24, and 48 hours after the end of IP infusion. 4 Hemostatic response (effective vs not effective) from the start of IP infusion to 24 hours after the start of IP infusion. 5 Change in z-scores for ROTEM EXTEM CT and TEG reaction time from baseline to 30 minutes, and 6 and 24 hours after the end of IP infusion. 6 Change in BSS score from baseline to 30 minutes after the end of IP infusion. 7 Universal Definition for Perioperative Bleeding classes based on events occurring during surgery or within the first postoperative day. 8 Total number of units of allogeneic blood products (ABPs) administered from the start of IP infusion and up to 5 days after surgery. 9 Total number of units of ABPs administered up to 24 hours after the start of IP infusion. 10 Number of units of individual ABPs administered up to 24 hours after the start of IP infusion. 11 Volume of chest tube output up to 24 hours after the end of study surgery. 12 Need for reoperation for bleeding and for other reasons up to 30 days after surgery. 13 Duration of mechanical ventilation up to 30 days after surgery. 14 Duration of primary intensive care unit stay and primary hospital stay up to 30 days after surgery. 15 28-Day and in-hospital mortality . 16 Treatment-emergent adverse events (TEAEs), serious TEAEs, and adverse events of special interest up to 30 days after IP infusion up to 30 days after surgery. 17 Change in plasma concentrations of coagulation FII, FVII, FIX, and FX, and Proteins C and S, from baseline to 30 minutes after the e | — |
Countries
Canada, Japan, Mexico, United States
Contacts
Public ContactHideto Akama
CSL Behring K.K.
Outcome results
None listed