Clotting Medication for Major Bleeding

Recruiting at 48 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

Trial Summary

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?

Bleeding complications are a common side effect of medications that prevent abnormal blood clotting, like anticoagulants and antiplatelet drugs. These complications can be serious, but better clinical management has reduced severe reactions over time. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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 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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adverse reactions to anticoagulants and to antiplatelet drugs recorded by the German spontaneous reporting system. [2022]

2. England pubmed.ncbi.nlm.nih.gov

An automated database case definition for serious bleeding related to oral anticoagulant use. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The safety of clopidogrel. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effect of i.v. tenoxicam during caesarean delivery on platelet activity. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Cardiovascular diseases, antiplatelet agents, anticoagulants and hemorrhagic risk]. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Aprotinin reduces clopidogrel-induced prolongation of the bleeding time in the rat. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Clopidogrel-related refractory bleeding after coronary artery bypass graft surgery: a rationale for the use of coagulation factor concentrates? [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Aprotinin and major orthopedic surgery. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Aprotinin reduces bleeding and blood product use in patients treated with clopidogrel before coronary artery bypass grafting. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A direct antifibrinolytic agent in major orthopedic surgery. [2021]