A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Sponsored by Takeda
About this trial
Last updated 9 months ago
Study ID
TAK-330-3001
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 3 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
Must be women and men 18 years or older.
Must be treated with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
Must need urgent surgery or other invasive procedures which have a high-risk of blood loss during surgery.
Exclusion Criteria
Cannot have an expected survival of less than 30 days.
Cannot be pregnant.
Additional entry criteria will be discussed with the study doctor.
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