A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

This study is looking for adults aged 18 or older who are currently taking a Factor Xa inhibitor blood thinner (like rivaroxaban, apixaban, or edoxaban).

To join, your surgeon must believe you need urgent surgery or a procedure within 15 hours of your last blood thinner dose, and that you need medicine to reverse the blood thinner's effect. If it's been longer than 15 hours, you might still qualify if blood tests show the blood thinner is still very active in your system. Women who could become pregnant will need a negative pregnancy test first.

There are also some reasons you wouldn't be able to join. These include if you have a very limited life expectancy, have recently experienced certain serious medical events (like a stroke or heart attack within 90 days), or are currently experiencing major bleeding that needs urgent treatment. Also, if you have certain blood clotting disorders or severe injuries where reversing the blood thinner alone wouldn't be enough, you wouldn't be suitable.

If you decide to take part, you'll first need to carefully read and sign a consent form, which explains everything about the study. You'll then be randomly assigned to receive either the new medicine (TAK-330) or the standard treatment (4F-PCC) just before your urgent surgery. Neither you nor the doctors will choose which treatment you get; it's decided by chance, like flipping a coin.

All participants will need to be admitted to the hospital for their surgery and the study treatment. Doctors will closely monitor you during and after your surgery. About 30 days after your surgery, the study team will contact you, either by phone or video call, to check on your recovery and gather some final information. The total duration of active participation is until this 30-day follow-up call.