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Study Summary
This trial is comparing the two options for reversing anticoagulation in people who require surgery while taking Factor Xa inhibitors. The study will involve people who are already hospitalized and will follow up with them after their surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am being treated with PROTHROMPLEX TOTAL as standard care.You have a history of IgA deficiency with allergic reactions and antibodies to IgA.I haven't had a stroke, heart attack, severe blood clotting issues, or been hospitalized for severe COVID-19 in the last 3 months.I have a blood clotting disorder.I have a known bleeding disorder.I do not have any major bleeding that needed surgery or more than 2 blood transfusions.I have septic shock with low blood pressure and high lactate levels despite treatment.I need urgent surgery and have a high bleeding risk due to recent Factor Xa inhibitor use.I haven't received blood products or specific clotting drugs in the last 7 days.I am not planning to use certain blood clotting drugs or blood products before starting the study treatment.You have had a condition called heparin-induced thrombocytopenia in the past.I am on dialysis for kidney failure.Your blood platelet count is less than 50,000 per microliter.You are allergic to any ingredients in TAK-330.I do not have severe liver failure.I have received heparin within the required time before joining the study.I am 18 years old or older.I am currently taking a blood thinner medication like rivaroxaban.I am of childbearing age and have a negative pregnancy test.I have multiple injuries where stopping blood thinners alone won't stop the bleeding.Your doctor thinks you might not live for more than 30 days, even with the best medical care.
- Group 1: TAK-330 25 IU/kg
- Group 2: SOC 4F-PCC
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How is PROTHROMPLEX TOTAL most often employed?
"PROTHROMPLEX TOTAL is often used as a treatment for hemorrhage, though it can also be useful in managing other conditions like anticoagulation, hemophilia b, and excessive bleeding."
Has the FDA cleared PROTHROMPLEX TOTAL for use?
"PROTHROMPLEX TOTAL falls on the third tier of our team's safety scale at Power. This is due to it being a Phase 3 trial, signifying that while there is data affirming its efficacy, there are also multiple rounds of data supporting its safety."
What is the participation rate in this research project?
"That is accurate. The online information from clinicaltrials.gov reports that this trial, which was initially posted on 8/24/2022, is still recruiting patients. A total of 328 individuals are needed for the study and so far, 1 site has been confirmed."
Have other doctors attempted anything similar to this experiment before?
"Research into PROTHROMPLEX TOTAL began in 2018. After the initial study, which was sponsored by CSL Behring and had 60 participants, Phase 3 clinical trials were approved. At present, there are 9 ongoing studies being conducted in 9 metropolitan areas and across 3 different nations."
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