A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N (Kcentra), for the reversal of vitamin K antagonist induced anticoagulation in patients needing urgent surgery with significant bleeding risk.
- Conditions
- Reversal of vitamin K antagonist (VKA) induced anticoagulation in patients needing urgent surgery associated with significant bleeding risk.MedDRA version: 20.0Level: PTClassification code 10065667Term: Haemorrhage prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2016-002649-41-RO
- Lead Sponsor
- Octapharma Pharmazeutika Produktionsges.m.b.H
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 370
1. Male or female patients at least 18 years of age.
2. Patients currently on oral anticoagulation treatment with VKA of coumadin or warfarin type.
3. Patients being admitted to the hospital or currently hospitalized where:
• an urgent surgery carrying significant bleeding risk (=50 mL expected blood loss) is required as part of routine clinical care;
• the use of oral or parenteral vitamin K alone to reverse anticoagulation is deemed too slow or inappropriate for reversal;
4. Patients with an INR of 2.0 or above at the time of decision to reverse the anticoagulation status.
5. Patients who have given written informed consent and who are able and willing to comply with the procedures laid out in the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 148
1. Patients with a life expectancy of less than 48 hours per physician’s judgment (e.g., patients with a Glasgow Coma Scale equal to 3 or a head Abbreviated Injury Score of 6, patients requiring continuous inotropic or pressor support, and patients whose status is post cardiac arrest).
2. Patients for whom the planned surgery or procedure is commonly associated with a very low bleeding risk (e.g., catheter placement, gastroscopy).
3. Patients with a history of TEEs, myocardial infarction (MI), unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, TIA, severe peripheral vascular disease, or disseminated intravascular coagulation within 3 months of enrollment.
4. Patients with a known congenital bleeding disorder.
5. Patients with a known antiphospholipid antibody syndrome.
6. Patients with present or past specific factor inhibitor activity.
7. Patients with thrombocytopenia of <80,000/µL or history of heparin-induced thrombocytopenia.
8. Patients who have received heparin of any type or any non-VKA anticoagulant within 24 hours prior to enrollment into the study or with potential need to receive these medications before completion of hemostasis evaluation at the end of surgery.
9. Patients who have received PCCs, FFP or vitamin K within 72 hours prior to enrollment into the study.
10. Patients with a known history of hypersensitivity to plasma-derived products.
11. Patients with acute major bleeding or polytrauma.
12. Pregnant or nursing women.
13. Patients participating in another interventional clinical study currently or during the past 30 day prior to enrollment into this study.
14. Patients previously enrolled in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method