Clotting Medication for Major Bleeding

Recruiting in Palo Alto (17 mi)

+49 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Octapharma

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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

I am taking blood thinners and my baseline anti-factor Xa activity is at least 100 ng/mL.

Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legally authorised representative

I am 18 years old or older.

+1 more

Exclusion Criteria

Pregnant or breastfeeding patients at the time of enrollment

I have had a heart attack, stroke, or blood clot in the last 3 months.

Patients with Hgb decrease without accompanying evidence of source of bleeding

+14 more

Participant Groups

The study is testing OCTAPLEX's effectiveness and safety at two different doses for patients experiencing severe bleeding while on DOAC therapy with a factor Xa inhibitor. It's a phase 3 trial where participants are randomly assigned to receive either a low-dose or high-dose of OCTAPLEX in an adaptive design that allows modifications based on interim results.

2Treatment groups

Experimental Treatment

Group I: Octaplex Low-doseExperimental Treatment1 Intervention

Participants to receive 1 Octaplex infusion intravenously

Group II: Octaplex High-doseExperimental Treatment1 Intervention

Participants to receive 1 Octaplex infusion intravenously