Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:11/1/2018
Start Date:June 8, 2017
End Date:June 2021
Contact:Mikaela Grupp
Email:ctgov@clinicalresearchmgt.com
Phone:866-337-1868

Use our guide to learn which trials are right for you!

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 (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K
Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is
clinically non-inferior to that Beriplex® P/N (Kcentra).

The primary objective of the study is to demonstrate that the efficacy of OCTAPLEX as a
reversal agent in patients under Vitami n K Antagonist (VKA)therapy with the need for urgent
surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N
(Kcentra).

The secondary objective of the study is to investigate the safety and tolerability of
OCTAPLEX compared to Beriplex® P/N (Kcentra) in patients under Vitamin K Antagonist (VKA)
therapy with the need for urgent surgery with significant bleeding risk.

Inclusion Criteria

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 international normalized ratio (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 described in the study protocol.

Exclusion Criteria

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 thromboembolic events (TEEs), myocardial infarction,
unstable angina pectoris, critical aortic stenosis, cerebrovascular accident,
transient ischemic attack, 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 prothrombin complex concentrates (PCCs), fresh frozen
plasma 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 days prior to enrollment into this study.

14. Patients previously enrolled in this study.
We found this trial at
15
sites
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Austin, Texas 78701
?
mi
from
Austin, TX
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
3467 Cleveland Avenue
Columbus, Ohio 43221
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Denver, Colorado 80045
?
mi
from
Denver, CO
Click here to add this to my saved trials
Fairborn, Ohio 45324
?
mi
from
Fairborn, OH
Click here to add this to my saved trials
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Lesnoy, 22304
?
mi
from
Lesnoy,
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15261
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
5306 Pacific Highway East
Puyallup, Washington 98374
?
mi
from
Puyallup, WA
Click here to add this to my saved trials
Rochester, New York 14642
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Round Rock, Texas 78665
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
8420 North Armenia Avenue
Tampa, Florida 33606
?
mi
from
Tampa, FL
Click here to add this to my saved trials