Study on TAK-330 for Reversing Anticoagulation in Patients on Factor Xa Inhibitors Needing Urgent Surgery

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What is this study about?

This clinical trial is focused on patients who are taking a type of medication called a Factor Xa Inhibitor and need urgent surgery or a procedure that has a high risk of bleeding. Factor Xa Inhibitors are medications that help prevent blood clots, but they can also increase the risk of bleeding during surgery. The study is testing a treatment called TAK-330, which is a solution for injection that contains several human proteins, including Human Coagulation Factor IX, Protein C, Human Coagulation Factor VII, Human Coagulation Factor II, and Human Coagulation Factor X. These proteins are involved in blood clotting and may help reverse the effects of Factor Xa Inhibitors.

The purpose of the study is to evaluate how well TAK-330 works compared to the standard treatment, known as 4F-PCC, in reversing the effects of Factor Xa Inhibitors in patients who need urgent surgery. The study will involve patients who have taken Factor Xa Inhibitors like rivaroxaban, apixaban, or edoxaban and require a reversal agent to manage bleeding risks during surgery. Participants will receive either TAK-330 or the standard treatment, and the effectiveness of the treatment will be assessed during and after the surgery.

The study will monitor the occurrence of effective blood clotting during and after the surgery, as well as any side effects or complications that may arise. The goal is to determine if TAK-330 can safely and effectively reverse the effects of Factor Xa Inhibitors, helping to manage bleeding risks in patients undergoing urgent surgical procedures. The trial is expected to continue until early 2027, with the aim of providing valuable information on the safety and efficacy of TAK-330 for patients in need of urgent medical interventions.

1 enrollment

Upon joining the study, you will be required to sign an informed consent form. This document confirms your willingness to participate and ensures you understand the trial’s purpose and procedures.

You must be at least 18 years old and currently taking a medication known as a Factor Xa inhibitor (such as rivaroxaban, apixaban, or edoxaban).

A negative pregnancy test is required for women of childbearing potential before enrollment.

2 screening

A screening process will determine your eligibility. This includes checking your blood levels to ensure they meet specific criteria related to the Factor Xa inhibitor you are taking.

If you require urgent surgery or a procedure with a high risk of bleeding, you may be eligible for the trial.

3 treatment administration

If eligible, you will receive the investigational product, TAK-330, or a standard treatment known as 4F-PCC. These are administered through an intravenous injection, which means they are given directly into a vein.

The purpose of these treatments is to reverse the effects of the Factor Xa inhibitor to reduce the risk of bleeding during your surgery or procedure.

4 surgery or procedure

You will undergo the planned surgery or procedure. The medical team will monitor the effectiveness of the treatment in controlling bleeding during this time.

The effectiveness will be assessed using a specific scale to ensure your safety and the success of the procedure.

5 postoperative monitoring

After the surgery or procedure, your condition will be monitored for 24 hours to assess the effectiveness of the treatment in controlling bleeding.

The medical team will also check for any side effects or complications that may arise from the treatment.

6 follow-up

You will be monitored for up to 30 days after the surgery or procedure to track any adverse events, such as unexpected side effects or complications.

The study will also record any occurrences of blood clots or other significant health events during this period.

Who Can Join the Study?

The patient or their legally authorized representative must be willing to sign an electronic or written informed consent form. This means they agree to participate in the study after understanding its details.
The patient must be at least 18 years old.
The patient must currently be taking an oral medication called a Factor Xa inhibitor. These include drugs like rivaroxaban, apixaban, or edoxaban, which help prevent blood clots.
The surgeon must believe that the patient needs urgent surgery or a procedure that has a high risk of bleeding during the operation. This must be within 15 hours of the last dose of the Factor Xa inhibitor, or if more than 15 hours have passed, the patient must have high levels of the drug in their blood, as shown by specific tests.
Women who can become pregnant must have a negative pregnancy test before joining the study.

Who Cannot Join the Study?

Patients who are not taking a medication called a Factor Xa Inhibitor. This is a type of blood thinner used to prevent blood clots.
Patients who do not need an urgent medical procedure or surgery that has a high risk of bleeding.
Patients who have not taken their last dose of the Factor Xa Inhibitor within the last 15 hours, unless their blood test shows high levels of the medication.
Patients whose blood test does not show high levels of the Factor Xa Inhibitor, which is measured in specific units (ng/mL or IU/mL).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaet Leipzig	Leipzig	Germany
Medical University Of Graz	Graz	Austria
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Rostock University Medical Center	Rostock	Germany
University Hospital Maastricht	Maastricht	The Netherlands
Pomeranian Medical University	Szczecin	Poland
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Ziekenhuis Oost Limburg	Genk	Belgium
Klinikum Dortmund gGmbH	Dortmund	Germany
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
General Hospital Of Nea Ionia Konstantopouleio Patision	Nea Ionia	Greece
University Of Debrecen	Debrecen	Hungary
Fakultni Nemocnice Brno	Brno	Czechia
Semmelweis University	Budapest	Hungary
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Jessa Ziekenhuis	Hasselt	Belgium
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)	Aveiro	Portugal
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
A.O. Krankenhaus St. Josef Braunau GmbH	Braunau Am Inn	Austria
BG Unfallklinik Murnau gGmbH	Murnau A. Staffelsee	Germany
Noe LGA Gesundheit Thermenregion GmbH	Neunkirchen	Austria
Ojpq Apzpjc Bfzgec Prj Kynvrk	Ozd	Hungary
Blxutqgjfxs Vxhdprtdj Oxsdtcrbyeha	Kecskemet	Hungary
Fqfsalar nyaavgxja Mgpcu a Hrqwjbg	Prague	Czechia
Garwnz Hdohfbdenms Ujmqdblramdgn Ptfrh Pkpqalorvbu Eo Nrzdobsvotaz	Paris	France
Hdsiwjjk Uwasagbakwfygs Sslkiogpth &owwrzc Hlifquz dk Hgmlabuwlzc	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	15.03.2023
Belgium	Recruiting	15.03.2023
Czechia	Recruiting	15.03.2023
France	Recruiting	15.03.2023
Germany	Recruiting	15.03.2023
Greece	Recruiting	15.03.2023
Hungary	Recruiting	15.03.2023
Poland	Recruiting	15.03.2023
Portugal	Recruiting	15.03.2023
Spain	Recruiting	15.03.2023
The Netherlands	Not recruiting	15.03.2023

Trial locations

Investigated drugs:

TAK-330 is a medication being tested to help reverse the effects of certain blood thinners, known as direct oral Factor Xa inhibitors. These blood thinners are used to prevent blood clots, but sometimes they need to be reversed quickly if a patient needs urgent surgery or an invasive procedure. TAK-330 is being studied to see if it can safely and effectively stop the blood-thinning effects, allowing doctors to perform necessary medical procedures without the risk of excessive bleeding.

4F-PCC stands for Four-Factor Prothrombin Complex Concentrate. It is a treatment that is already used in medical practice to reverse the effects of blood thinners. It works by providing the body with clotting factors that help the blood to clot more normally. In this trial, 4F-PCC is being used as a standard treatment to compare its effectiveness and safety against TAK-330 in patients who need their blood thinners reversed quickly for surgery or other procedures.

Investigated diseases:

Thrombosis prophylaxis

Bleeding Risk Associated with Factor Xa Inhibitors – This condition occurs in patients who are taking Factor Xa inhibitors, a type of anticoagulant medication, and require urgent surgical or invasive procedures. Factor Xa inhibitors work by preventing blood clots, but they can increase the risk of bleeding during surgery. The progression involves the potential for significant bleeding during or after the procedure, which can complicate surgical outcomes. The bleeding risk is particularly high if the surgery is performed within a short time after the last dose of the medication. Managing this condition involves careful monitoring and assessment of bleeding during and after the procedure.

Trial ID:

2022-503012-16-00

Protocol code:

TAK-330-3001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on TAK-330 for Reversing Anticoagulation in Patients on Factor Xa Inhibitors Needing Urgent Surgery

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