The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure. The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery. Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
328
Participants will receive TAK-330, 25 IU/kg single intravenous infusion on Day 1 and an additional dose of 25 IU/kg TAK-330 can be administered if required.
Participants will receive 4F-PCC as SOC on Day 1. The dose and infusion speed of the SOC 4F-PCC will be based on local institutional protocols. An additional dose of SOC 4F-PCC not exceeding total dose of 50 IU/kg or 5,000 IU, whichever is smaller can be given during the surgery if required.
University of Arkansas Medical Sciences
Arkansas City, Arkansas, United States
RECRUITINGUniversity of California Davis Health System
Sacramento, California, United States
RECRUITINGDenver Metro Orthopedics, P.C.
Englewood, Colorado, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
Percentage of Participants With Intraoperative Effective Hemostasis
Percentage of participants achieving intraoperative effective hemostasis, as determined by the Intraoperative Four Point Hemostatic Efficacy Scale and assessed by the principal investigator (PI), the surgeon, or a qualified member of the surgical team.
Time frame: At the end of the surgery/procedure
Percentage of Participants With Postoperative Effective Hemostasis
Percentage of participants achieving postoperative effective hemostasis at 24±4 hours following the completion of investigational product infusion, as determined by the Postoperative Four Point Hemostatic Efficacy Scale and assessed by the PI, the surgeon, or a qualified member of the surgical team.
Time frame: At 24 hours after the end of investigational product infusion
Percentage of Participants With Intraoperative Effective Hemostasis Based on Hemostatic Efficacy Rating Algorithm
Percentage of participants achieving intraoperative effective hemostasis, as determined by the Hemostatic Efficacy Rating Algorithm and assessed by the PI, the surgeon, or a qualified member of the surgical team.
Time frame: At the end of the surgery/procedure
Number of Participants With Usage of Blood Products or Non-Study Hemostatic Agents for Bleeding Control
Number of participants with usage of blood products or non-study hemostatic agents for bleeding control will be documented from the end of IP infusion to 24 hours after end of study product infusion.
Time frame: Within 24 hours after the end of investigational product infusion
Number of Units of Packed Red Blood Cells (PRBCs) Administered to Achieve Bleeding Control
Number of units of PRBCs administered to achieve bleeding control within 24 hours after the end of IP infusion.
Time frame: Within 24 hours after the end of investigational product infusion
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
An Adverse Event (AE) is defined as any untoward medical occurrence (including a symptom or disease or an abnormal laboratory finding) in a participant or clinical investigation participants administered a medicinal product and which does not necessarily have a causal relationship with the treatment. TEAEs are defined as those with a start date on or after the first dose of study treatment, or with a start date before the date of first dose of study treatment but increasing in severity after the first dose of study treatment. A SAE is any event that results in: death; life-threatening event; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or a medically important event. AESI will include hypersensitivity reactions, events of disordered coagulation such as bleeding and hypercoagulability.
Time frame: Within 30 days after the end of the surgery/invasive procedure (up to 33 days)
Number of Participants With Thrombotic Events
Number of thrombotic events within 30 days after the end of the surgery/invasive procedure will be assessed. Thrombotic events occur when a blood clot, known as a thrombus, is formed within a blood vessel. It prevents blood from flowing normally through the circulatory system.
Time frame: Within 30 days after the end of the surgery/invasive procedure (up to 33 days)
Number of Participants With Deaths Within 30 Days Post-Surgery/Invasive Procedure
Number of deaths Within 30 days post-surgery/invasive procedure will be assessed.
Time frame: Within 30 days post-surgery/invasive procedure (up to 33 days)
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Rutgers, The State University of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGECU Health Medical Center
Greenville, North Carolina, United States
RECRUITINGMetro Health Medical Center
Cleveland, Ohio, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGAscension St. John Medical Center
Tulsa, Oklahoma, United States
RECRUITINGUniversity of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, United States
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