OCTAPLEX for Major Bleeding in Patients on Blood Thinners

We are studying whether a higher dose of OCTAPLEX can effectively stop major bleeding in patients taking direct oral anticoagulants. The trial also looks at the safety of this treatment during emergencies.

≤3 months Confirmation phase (III)No Placebo Standard Medicines InjectionHematology

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What medicines are being studied?

Medicines that are officially approved for use in the European Union and considered safe by EMA. These medicines are already on the market and may be tested for new conditions or populations.

Octaplex

Octaplex is a medicine used to quickly restore blood clotting factors to stop or prevent serious bleeding, especially in people taking blood-thinning drugs.

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Human Coagulation Factor Ii

Human Coagulation Factor II is a protein that helps blood clot and can replace missing clotting factor in people with bleeding disorders.

Human Coagulation Factor Ix

Human coagulation Factor IX is a protein that helps blood clot and is used to prevent and control bleeding in people with hemophilia B.

Human Coagulation Factor Vii

Human Coagulation Factor VII is a substance that helps blood clot to control bleeding in people with certain clotting disorders.

What similar medicines might you know?

Don't worry if you don't know the medicines tested in the trial. There is a chance you have heard about the similar medicines. Check the list below to see if you are familiar with any of them.

Alphanate

Beriate

Beriate 1000

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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Medizinische Universitaet Innsbruck

Department for Anaesthesiology and Intensive Care Medicine

Innsbruck, Austria

Clinical Hospital Dubrava

Department of Intensive Care Medicine (Zavod za intenzivnu medicinu)

Zagreb, Croatia

KBC Zagreb

Department of Hematology (Zavod za Hematologiju)

Zagreb, Croatia

Sponsor: Octapharma AG

Last updated: Nov 27, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.