Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 1, 2015

Primary Completion Date

July 6, 2016

Study Completion Date

July 6, 2016

Conditions
Von Willebrand Disease
Interventions
BIOLOGICAL

Recombinant von Willebrand Factor (rVWF)

rVWF will be administered by intravenous bolus infusion. Participants planned for major surgery will undergo a baseline pharmacokinetic assessment prior to surgery. The peri- and postoperative substitution regimen will be individualized according to the PK results, intensity and duration of the hemostatic challenge, and the institution´s standard of care.

Trial Locations (34)

1090

AKH - Medizinische Universität Wien, Vienna

5000

Royal Adelaide Hospital, Adelaide

6000

Fiona Stanley Hospital, Perth

6009

The Perth Blood Institute, Nedlands

10002

Tri-Service General Hospital, Taipei

11490

National Taiwan University Hospital, Taipei

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

21205

John Hopkins University, Baltimore

27705

Duke University Medical Center, Durham

29425

Medical University of South Carolina (MUSC), Charleston

30912

Georgia Regents University, Augusta

33136

University of Miami, Jackson Memorial Hospital, Miami

35100

Ege University Medical Faculty, Izmir

40705

Taichung Veterans General Hospital, Taichung

44106

Case Western Reserve University Hospital, Cleveland

44195

Cleveland Clinic, Cleveland

46026

Hospital Universitari i Politècnic La Fe, Valencia

50139

Azienda Ospedaliero - Universitaria Careggi, Firenze (Florence)

53233

Blood Center of South East Wisconsin, Milwaukee

55101

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

70852

Fakultni nemocnice Ostrava, Ostrava

73104

University of Oklahoma Health Sciences Center, Oklahoma City

79044

SI Institute of Blood Pathology and Transfusion Medicine of NAMSU, Lviv

80045

University of Colorado Hemophilia & Thrombosis Center, Aurora

610027

FSI Kirov Institute of Hematology and Blood Transfusion FMBA, Kirov

656024

"Regional Budgetary State Healthcare Institution (SHI) Regional Clinical Hospital", Barnaul

02215

Dana Farber Cancer Institute, Boston

08901

Rutgers - Robert Wood Johnson Medical School, New Brunswick

00144

Umberto I Policlinico di Roma, Universitá di Roma La Sapienza, Rome

3015 CE

Erasmus Medisch Centrum, Rotterdam

PL6 8DH

Derriford Hospital, Plymouth

NW3 2QG

Royal Free Hospital, London

OX3 7LJ

Churchill Hospital, Oxford

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT02283268 - Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery | Biotech Hunter | Biotech Hunter