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TAK-330 vs 4F-PCC for Reversal of Factor Xa Inhibitor-induced Anticoagulation in Urgent Surgery
NCT05156983Phase 3
Key facts
- Status
- Recruiting
- Start
- Aug 2022
- Primary completion
- Aug 2028
- Countries
- 15
- Sponsor
- Takeda
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Prothromplex Total
- Conditions
- coagulation disorder
01
Overview
Phase 3, randomised, open-label trial of Prothromplex Total in coagulation disorder (2 arms), sponsored by Takeda. Primary endpoint: Percentage of Participants With Intraoperative Effective Hemostasis. Started Aug 2022; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
TAK-330 25 IU/kg
TAK-330, 25 IU/kg single IV infusion on Day 1 prior to surgery. Additional dose of 25 IU/kg possible during surgery. Max 50 IU/kg or 5,000 IU.
SOC 4F-PCC
4F-PCC as standard of care on Day 1 prior to surgery. Additional dose possible during surgery. Max 50 IU/kg or 5,000 IU.
03
Who it enrols
Adults requiring urgent surgery with high risk of bleeding within 15 hours of taking an oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban), excluding those with severe liver/renal failure, recent thrombotic events, or active major bleeding.
04
Endpoints
Primary
Percentage of Participants With Intraoperative Effective Hemostasis
Secondary
Percentage of Participants With Postoperative Effective Hemostasis
Percentage of Participants With Intraoperative Effective Hemostasis Based on Hemostatic Efficacy Rating Algorithm
Number of Participants With Usage of Blood Products or Non-Study Hemostatic Agents for Bleeding Control
Number of Units of Packed Red Blood Cells (PRBCs) Administered to Achieve Bleeding Control
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
Number of Participants With Thrombotic Events
Number of Participants With Deaths Within 30 Days Post-Surgery/Invasive Procedure
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