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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
In the opinion of the surgeon, the participant requires an urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (>) 75 nanograms per milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of >0.5 international unit per milliliter (IU/mL) at screening
Participants at least 18 years of age at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of the surgery/procedure
Awards & highlights
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.
Who is the study for?
Adults on oral Factor Xa inhibitors needing urgent surgery with high bleeding risk can join. They must have a negative pregnancy test if applicable, and either took their last dose of the inhibitor within 15 hours or show elevated anti-FXa levels. Excluded are those with certain clotting/bleeding disorders, severe organ failure, recent use of heparin or other trials, breastfeeding women, imminent death prognosis, recent major cardiovascular events or active major bleeding.Check my eligibility
What is being tested?
The trial is testing TAK-330 against standard treatment (4F-PCC) for reversing anticoagulation from Factor Xa inhibitors in patients requiring urgent surgery. Participants will be randomly assigned to one of these treatments before their procedure and followed up via telehealth after 30 days.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, increased risk of blood clots due to reversal agents like PCC constituents in TAK-330 or SOC 4F-PCC, and complications related to underlying conditions that necessitate urgent surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need urgent surgery and have a high bleeding risk due to recent Factor Xa inhibitor use.
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I am 18 years old or older.
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I am currently taking a blood thinner medication like rivaroxaban.
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I am of childbearing age and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours after the end of investigational product infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours after the end of investigational product infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Intraoperative Effective Hemostasis
Secondary outcome measures
Number of Participants With Deaths Within 30 Days Post-Surgery/Invasive Procedure
Number of Participants With Thrombotic Events
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TAK-330 25 IU/kgExperimental Treatment1 Intervention
Participants will receive TAK-330, 25 international unit per kilogram (IU/kg) single intravenous infusion on Day 1 (prior to surgery) as an initial dose and an additional dose of 25 IU/kg TAK-330 can be administered during the surgery if deemed necessary by the surgeon. The total dose of TAK-330 administered to the participant should not exceed 50 IU/kg or 5,000 IU, whichever is smaller.
Group II: SOC 4F-PCCActive Control1 Intervention
Participants will receive 4F-PCC (excluding Prothromplex Total and activated 4F-PCC) as standard of care (SOC) on Day 1 (prior to surgery). 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.
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Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,934 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,702 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,352 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: TAK-330 25 IU/kg
- Group 2: SOC 4F-PCC
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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