Clotting Medication for Major Bleeding

Recruiting at 57 trial locations

Overseen By Sigurd Knaub, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Octapharma

Must be taking: Factor Xa inhibitors

Must not be taking: Ticlopidine, Prasugrel, Ticagrelor, others

Disqualifiers: DNR orders, Acute trauma, ACS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Octaplex, a clotting agent, to stop major bleeding in people taking blood thinners that affect clotting factors. Researchers aim to determine whether a low or high dose best controls bleeding safely and effectively. The trial suits individuals on factor Xa inhibitor blood thinners who experience severe, life-threatening bleeding or bleeding in critical organs. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to potentially life-saving treatment advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Octaplex is generally safe. One study found that Octaplex had a safety level similar to another treatment, with both groups experiencing comparable side effects.

Another study demonstrated that Octaplex effectively stopped bleeding without increasing the risk of blood clots. This finding is significant because it indicates that the treatment works well and is less likely to cause dangerous side effects like clots.

Overall, Octaplex has been well-tolerated by people needing urgent treatment for bleeding. No major safety issues have been reported during its use in similar situations. This suggests that Octaplex could be a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about Octaplex for treating major bleeding because it offers a potentially faster and more targeted approach compared to traditional blood-clotting treatments like fresh frozen plasma (FFP) or prothrombin complex concentrates (PCCs). Unlike these standard options, which may require multiple infusions over a longer period, Octaplex is administered as a single intravenous infusion, which could mean quicker stabilization of bleeding. This efficiency in delivery might not only improve patient outcomes but also enhance convenience during emergency situations.

What evidence suggests that Octaplex could be an effective treatment for major bleeding?

Studies have shown that Octaplex, a treatment that aids blood clotting, effectively controls major bleeding. Research indicates that Octaplex manages bleeding better than frozen plasma, particularly during surgery. This treatment provides clotting factors that help stop bleeding in patients taking blood thinners like factor Xa inhibitors. In this trial, participants will receive either a low or high dose of Octaplex. Initial findings suggest that both doses can help control bleeding, though the high dose might be more effective. These insights offer a promising solution for patients experiencing severe bleeding while on certain blood thinners. ^{1 2 6 7 8}

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

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

I am currently experiencing severe bleeding.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single infusion of either low-dose or high-dose OCTAPLEX intravenously

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of thromboembolic events and adverse events

30 days

Multiple visits (in-person and virtual)

Hospitalization

Participants may be hospitalized for monitoring and management of acute major bleeding

1-3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Octaplex

Trial Overview 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.

How Is the Trial Designed?

Group I: Octaplex Low-dose Experimental Treatment 1 Intervention

Participants to receive 1 Octaplex infusion intravenously

Group II: Octaplex High-dose Experimental Treatment 1 Intervention

Participants to receive 1 Octaplex infusion intravenously

Who Is Running the Clinical Trial?

Octapharma

Lead Sponsor

Trials

86

Recruited

11,300+

Wolfgang Marguerre

Octapharma

Chief Executive Officer since 1983

MBA from INSEAD

Wolfgang Frenzel

Octapharma

Chief Medical Officer since 2010

MD from University of Vienna

Published Research Related to This Trial

Anticoagulants and antiplatelet drugs are the most frequently reported causes of adverse drug reactions (ADRs) in Germany, with heparins, ticlopidine, phenprocoumon, acetylsalicylic acid, and clopidogrel being the most commonly implicated drugs.

There has been a notable reduction in severe ADRs, such as fatal cerebral hemorrhages, due to improved management of oral anticoagulant therapy and better handling of adverse events related to heparin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions to anticoagulants and to antiplatelet drugs recorded by the German spontaneous reporting system. Tiaden, JD., Wenzel, E., Berthold, HK., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04867837

Study of OCTAPLEX in Patients With Acute Major Bleeding ... Phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1473050225000497

Twenty years of the four-factor prothrombin complex ... This narrative review summarizes published efficacy and safety data on one 4F-PCC (Octaplex/Balfaxar, Octapharma) within its recognized uses.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11723492/

Four-factor Prothrombin Complex Concentrate Use for ... Implementing an anticoagulant protocol has proven effective in decreasing time to surgery without increasing the risk of bleeding. Current ...

4. octapharma.ca octapharma.ca/en/news/press-release/2025/jama-publishes-fares-ii-study-confirming-the-superior-hemostatic-efficacy-of-octaplex-4f-pcc-over-frozen-plasma-in-cardiac-surgery

JAMA Publishes Groundbreaking FARES-II Study ... Octaplex (4F-PCC) provides superior hemostatic efficacy compared to Frozen Plasma (FP) for bleeding management in cardiac surgery.

5. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/1256/501498/Updated-Protocol-for-the-Phase-3-Randomized-Double

Updated Protocol for the Phase 3, Randomized, Double ... This study aims to evaluate superior hemostatic efficacy of high-dose vs low-dose four-factor (4F) PCC (Octaplex®; Octapharma) in adults with FXaI-related ...

6. ashpublications.org ashpublications.org/blood/article/116/21/3344/66206/the-Efficacy-and-Safety-of-Prothrombin-Complex

the Efficacy and Safety of Prothrombin Complex Concentrate ... Conclusion: Octaplex is efficient and appears to be safe in the urgent reversal of INR in patients taking vitamin K antagonists. Disclosures: ...

7. octapharma.com octapharma.com/news/press-release/2025/Octapharma-announces-superior-haemostatic-efficacy-of-4f-pcc-over-frozen-plasma-in-cardiac-surgical-bleeding

Octapharma Announces Superior Haemostatic Efficacy of ... The study found that octaplex®/Balfaxar® (4F-PCC) improved haemostatic outcomes by 17.6% over FP, without increasing thromboembolic risk.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15226091/

Efficacy and safety of a prothrombin complex concentrate ... Octaplex administration was uneventful in all patients. Following Octaplex administration, a small increase in F1+2 levels was observed in bleeding patients, ...