Is NCT05156983 recruiting in Englewood, CO?

Yes, NCT05156983 is currently recruiting participants at its Englewood, CO location. This blood clot medication reversal clinical trial is actively enrolling qualified participants.

How do I join the blood clot medication reversal clinical trial in Englewood?

To join this clinical trial in Englewood, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Englewood clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Blood clot medication reversal Clinical Trial in Englewood, CO

About This Blood clot medication reversal Study in Englewood

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 hospitalize

Sponsor: Takeda

Who Can Participate

Inclusion Criteria

Participant or legally authorized representative willing to sign e-consent/written informed consent form.

Participants at least 18 years of age at enrollment.

Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).

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.

Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.

Exclusion Criteria

The participant has an expected survival of less than 30 days, even with best available medical and surgical care.

Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), disseminated intravascular coagulation (DIC), ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.

Active major bleeding defined as bleeding that requires surgery or transfusion of \>2 units of packed red blood cell (PRBC) or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) greater than or equal to (\>=) 9.

Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.

Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.

Known bleeding disorder (example, platelet function disorders, hemophilia, Von Willebrand disease, or coagulation factor deficiency).

Platelet count less than (\<) 50,000 per microliter (/mcL).

History of heparin-induced thrombocytopenia.

Administration of procoagulant drugs (example, non-study prothrombin complex concentrates (PCCs), recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) within 7 days before enrollment. (Note: administration of PRBCs for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteria).

Planned use of procoagulant drugs (example, Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of tranexamic acid (TXA) or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these participants in the interactive response technology (IRT). Planned administration of TXA or aminocaproic acid after start of IP infusion but before the 24±4 hours hemostatic assessment is prohibited. Administration of any of the above products before the 24±4 hours hemostatic assessment will impact the assessment of hemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusion criterion.

Administration of unfractionated heparin within 2 hours before randomization or low molecular weight heparin within 6 hours before randomization.

Hypersensitivity to PCC constituents or any excipient of TAK-330.

Participants with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.

Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) \>=65 millimeters of mercury (mmHg) and having blood lactate \>2 millimole (mmol) despite adequate volume resuscitation.

Acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)

Renal failure requiring dialysis

Any other condition that could, in the opinion of the investigator, put the participant at undue risk of harm if the participant were to participate in the study.

Participation in another clinical study involving an investigational product or device within 30 days prior to study enrollment, or planned participation in another clinical study involving an investigational product or device during the course of this study. Participation in an observational study is not an exclusion criterion.

The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.

Women who are breastfeeding at the time of enrollment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Englewood?

Yes, this clinical trial (NCT05156983) has an active research site in Englewood, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Blood clot medication reversal Treatment Options in Englewood, CO

If you're searching for blood clot medication reversal treatment options in Englewood, CO, this clinical trial (NCT05156983) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Englewood research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced blood clot medication reversal specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all blood clot medication reversal clinical trials near you to find additional studies recruiting in your area.

Blood clot medication reversal Clinical Trial in Englewood, CO

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