Clotting Medication for Major Bleeding
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests OCTAPLEX, a medication that helps blood to clot, in patients with severe bleeding who are on blood thinners. It works by providing essential proteins needed for blood clotting.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are on an oral factor Xa inhibitor. Some medications like ticlopidine, prasugrel, ticagrelor, dipyridamole, and cangrelor must not have been taken within a certain period before the bleeding event.
Is the clotting medication Octaplex generally safe for humans?
How does the drug Octaplex differ from other treatments for major bleeding?
Octaplex is unique because it is a coagulation factor concentrate, which means it directly provides the necessary components to help blood clot, unlike other treatments that may work by inhibiting bleeding pathways or enhancing platelet function. This makes it particularly useful in situations where conventional hemostatic therapies are ineffective.678910
Are You a Good Fit for This Trial?
Adults (≥18 years) on oral factor Xa inhibitor therapy with acute major bleeding, defined as life-threatening or uncontrolled bleeding, symptomatic critical organ bleeding, or significant drop in hemoglobin. Participants must have anti-factor Xa activity ≥100 ng/mL and provide informed consent. Excluded are those with recent trauma, certain cardiovascular events, coagulation disorders, known hypersensitivity to plasma products, prior use of specific haemostatic agents for the current bleed or participation in another clinical trial within the last month.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single infusion of either low-dose or high-dose OCTAPLEX intravenously
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of thromboembolic events and adverse events
Hospitalization
Participants may be hospitalized for monitoring and management of acute major bleeding
What Are the Treatments Tested in This Trial?
Interventions
- Octaplex
Find a Clinic Near You
Who Is Running the Clinical Trial?
Octapharma
Lead Sponsor
Wolfgang Marguerre
Octapharma
Chief Executive Officer since 1983
MBA from INSEAD
Wolfgang Frenzel
Octapharma
Chief Medical Officer since 2010
MD from University of Vienna