Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

479

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Acquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary Bypass
Interventions
DRUG

catridecacog

Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

DRUG

catridecacog

Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

DRUG

placebo

Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Trial Locations (32)

2100

Novo Nordisk Investigational Site, København Ø

13353

Novo Nordisk Investigational Site, Berlin

18105

Novo Nordisk Investigational Site, Allentown

19107

Novo Nordisk Investigational Site, Philadelphia

20097

Novo Nordisk Investigational Site, San Donato Milanese (MI)

20132

Novo Nordisk Investigational Site, Milan

27710

Novo Nordisk Investigational Site, Durham

28007

Novo Nordisk Investigational Site, Madrid

28034

Novo Nordisk Investigational Site, Madrid

40138

Novo Nordisk Investigational Site, Bologna

46026

Novo Nordisk Investigational Site, Valencia

49100

Novo Nordisk Investigational Site, Petah Tikva

52621

Novo Nordisk Investigational Site, Ramat Gan

60590

Novo Nordisk Investigational Site, Frankfurt am Main

67063

Novo Nordisk Investigational Site, Ludwigshafen

77030

Novo Nordisk Investigational Site, Houston

80636

Novo Nordisk Investigational Site, München

30322-1059

Novo Nordisk Investigational Site, Atlanta

97239-3098

Novo Nordisk Investigational Site, Portland

02905

Novo Nordisk Investigational Site, Providence

M5B 1W8

Novo Nordisk Investigational Site, Toronto

H1T 1C8

Novo Nordisk Investigational Site, Montreal

K1Y 4W7

Novo Nordisk Investigational Site, Ottawa

G1V 4G5

Novo Nordisk Investigational Site, Québec

M5G-2C4

Novo Nordisk Investigational Site, Toronto

020-8505

Novo Nordisk Investigational Site, Numakunai

565-8565

Novo Nordisk Investigational Site, Osaka

113-843

Novo Nordisk Investigational Site, Tokyo

221 85

Novo Nordisk Investigational Site, Lund

CB23 3RE

Novo Nordisk Investigational Site, Cambridge

S5 7AU

Novo Nordisk Investigational Site, Sheffield

SO16 6YD

Novo Nordisk Investigational Site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00914589 - Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery | Biotech Hunter | Biotech Hunter