TAK-330-3001 - A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

Conditions

Patients on treatment with Factor Xa Inhibitor needing for an urgent intervention associated with a high risk of bleeding.

Brief summary

Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Intraoperative Hemostatic Efficacy Scale (Section 8.2.2.1).

Detailed description

Key Secondary Endpoint: Occurrence of postoperative effective hemostasis assessed at 24 hours after the end of investigational product infusion (TAK-330 or comparator 4F-PCC) based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Postoperative Hemostatic Efficacy Scale (Section 8.2.2.1)., • Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Hemostatic Efficacy Rating Algorithm (Section 8.2.2.2)., • Usage of blood products or non-study hemostatic agents for bleeding control within 24 hours after the end of investigational product infusion., • Number of units of packed red blood cells (PRBCs) administered to achieve bleeding control within 24 hours after the end of investigational product infusion., • Occurrence of serious adverse events (SAEs), and/or adverse events (AEs), treatment emergent AEs (TEAEs), and adverse events of special interest (AESIs) within 30 days after the end of the surgery/invasive procedure., • Occurrence of thrombotic events within 30 days after the end of the surgery/invasive procedure., • All-cause deaths within 30 days post-surgery/invasive procedure.

Related papers

No related papers found yet.

Interventions

DRUGPROTHROMPLEX TOTAL®

DRUGCOAGULATION FACTOR IX

DRUGII

DRUGVII AND X IN COMBINATION

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Intraoperative Hemostatic Efficacy Scale (Section 8.2.2.1).	—

Secondary

Measure	Time frame
Key Secondary Endpoint: Occurrence of postoperative effective hemostasis assessed at 24 hours after the end of investigational product infusion (TAK-330 or comparator 4F-PCC) based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Postoperative Hemostatic Efficacy Scale (Section 8.2.2.1)., • Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Hemostatic Efficacy Rating Algorithm (Section 8.2.2.2)., • Usage of blood products or non-study hemostatic agents for bleeding control within 24 hours after the end of investigational product infusion., • Number of units of packed red blood cells (PRBCs) administered to achieve bleeding control within 24 hours after the end of investigational product infusion., • Occurrence of serious adverse events (SAEs), and/or adverse events (AEs), treatme	—

Measure

Time frame

Key Secondary Endpoint: Occurrence of postoperative effective hemostasis assessed at 24 hours after the end of investigational product infusion (TAK-330 or comparator 4F-PCC) based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Postoperative Hemostatic Efficacy Scale (Section 8.2.2.1)., • Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Hemostatic Efficacy Rating Algorithm (Section 8.2.2.2)., • Usage of blood products or non-study hemostatic agents for bleeding control within 24 hours after the end of investigational product infusion., • Number of units of packed red blood cells (PRBCs) administered to achieve bleeding control within 24 hours after the end of investigational product infusion., • Occurrence of serious adverse events (SAEs), and/or adverse events (AEs), treatme

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Countries

Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Netherlands, Poland, Portugal, Spain

Outcome results

None listed