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.

PHASE3CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

June 8, 2017

Primary Completion Date

February 23, 2022

Study Completion Date

February 23, 2022

Conditions
Significant Bleeding Risk
Interventions
DRUG

Octaplex

OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).

DRUG

Beriplex P/N (Kcentra)

Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min).

Trial Locations (86)

1000

Octapharma Research Site, Sofia

Octapharma Study Site, Sofia

2004

Octapharma Research Site, Chisinau

2100

Octapharma Research Site, Zugdidi

4002

Octapharma Research Site, Plovdiv

4600

Octapharma Research Site, Kutaisi

6010

Octapharma Research Site, Batumi

7002

Octapharma Research Site, Rousse

9010

Octapharma Research Site, Varna

12430

Octapharma Research Site, Zhytomyr

12559

Octapharma Research Site, Berlin

14642

Octapharma Research Site, Rochester

15213

Octapharma Research Site, Pittsburgh

Octapharma Study Site, Pittsburgh

15219

Octapharma Research Site, Pittsburgh

15232

Octapharma Research Site, Pittsburgh

15237

Octapharma Research Site, Pittsburgh

18009

Octapharma Research Site, Cherkasy

21018

Octapharma Research Site, Vinnytsia

25006

Octapharma Research Site, Kropyvnytskyi

27710

Octapharma Research Site, Durham

33136

Octapharma Research Site, Miami

33606

Octapharma Research Site, Tampa

43006

Octapharma Research Site, Lutsk

43210

Octapharma Research Site, Columbus

44109

Octapharma Research Site, Cleveland

45324

Octapharma Research Site, Fairborn

45409

Octapharma Research Site, Dayton

46026

Octapharma Research Site, Valencia

49005

Octapharma Research Location, Dnipro

Octapharma Research Site, Dnipro

49102

Octapharma Research Site, Dnipro

52242

Octapharma Research Site, Iowa City

58001

Octapharma Research Site, Chernivtsi

60590

Octapharma Research Site, Frankfurt am Main

61037

Octapharma Research Site, Kharkiv

61103

Octapharma Research Site, Kharkiv

65006

Octapharma Research Site, Odesa

69000

Octapharma Research Site, Zaporizhzhya

69120

Octapharma Research Site, Heidelberg

75390

Octapharma Research Site, Dallas

76018

Octapharma Research Site, Ivano-Frankivsk

78665

Octapharma Research Site, Round Rock

78701

Octapharma Research Site (0115), Austin

Octapharma Research Site (0127), Austin

79010

Octapharma Research Site, Lviv

79034

Octapharma Research Site, Lviv

80045

Octapharma Research Site, Aurora

98374

Octapharma Research Site, Puyallup

105203

Octapharma Research Site, Moscow

111539

Octapharma Research Site, Moscow

115446

Octapharma Research Site, Moscow

124489

Octapharma Research Site, Moscow

170036

Octapharma Research Site, Tver'

192242

Octapharma Research Site, Saint Petersburg

194354

Octapharma Research Site, Saint Petersburg

Octapharma Research Site, Saint Petersburg

197022

Octapharma Research Site, Saint Petersburg

200624

Octapharma Research Site, Craiova

214019

Octapharma Research Site, Smolensk

220024

Octapharma Research Site, Minsk

220032

Octapharma Research Site, Minsk

220040

Octapharma Research Site, Minsk

223040

Octapharma Research Site, Lesnoy

400006

Octapharma Research Site, Cluj-Napoca

410053

Regional Clinical Hospital, Saratov

410167

Octapharma Research Site, Oradea

620026

Octapharma Research Site, Yekaterinburg

630055

Octapharma Research Site, Novosibirsk

644111

Octapharma Research Site, Omsk

3000723

Octapharma Research Site, Timișoara

06510

Octapharma Research Site, New Haven

02114

Octapharma Research Site, Boston

00114

Octapharma Research Site - Tbilisi, Tbilisi

00167

Octapharma Research Location - Tbilisi, Tbilisi

0141

Octapharma Research Site, Tbilisi

0159

Octapharma Research Location, Tbilisi

Octapharma Research Site, Tbilisi

01307

Octapharma Research Site, Dresden

32-700

Octapharma Research Site, Bochnia

95-513

Octapharma Research Site, Lodz

010825

Octapharma Research Site, Bucharest

020475

Octapharma Research Site, Bucharest

08907

Octapharma Research Site, Barcelona

07120

Octapharma Research Site, Palma de Mallorca

01133

Octapharma Research Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY

NCT02740335 - 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. | Biotech Hunter | Biotech Hunter