Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

March 31, 2010

Conditions
Total Knee Replacement Surgery
Interventions
DRUG

TB-402

TB-402 administered as single bolus 18-24 post total knee replacement surgery.

DRUG

Enoxaparin

Enoxaparin 40mg/day sc injection for at least 10 days post-surgery

Trial Locations (35)

1709

"MHAT Sveta Anna AD - Sofia, Clinic of Orthopedics and Traumatology", Sofia

4002

"Dept. of Orthopedics, UMHAT Saint George", Plovdiv

5800

"SHAT of orthopedics, traumatology and surgery Sv. Pantaleimon - Pleven Department of Orthopaedics and Traumatology", Pleven

7002

MHAT Rousse, Rousse

9000

"MHAT Sv. Anna, Department of Orthopaedics and Traumatology", Varna

18009

Cherkasska Regional Hospital. Department of Orthopedics and Traumatology., Cherkassy

31096

Rambam MC, Haifa

44281

Meir Medical Center (MC), Kfar Saba

49100

Beilinson Hospital, Petah Tikva

64239

Sourasky MC, Tel Aviv

65025

Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology, Odesa

70300

Asaf Harofeh MC, Beer-Yaakov

76008

Ivano-Frankіvsk Regional Clinical Hospital, Department of ortopedics and traumatology., Ivano-Frankivsk

76100

Kaplan MC, Rehovot

84101

Soroka MC, Beersheba

91031

Shaare Zedek MC, Jerusalem

111539

"Moscow State Healthcare Institution City Clinical Hospital No. 15 n.a. O.M. Filatov", Moscow

193312

"Saint Petersburg State Healthcare Institution Aleksandrovskaya Hospital", Saint Petersburg

194291

Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency, Saint Petersburg

194354

"Saint Petersburg State Healthcare Institution Municipal Multi-Speciality Hospital No. 2", Saint Petersburg

197046

"Federal State Institution Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden under the Federal Authority for Healthcare and Social Development", Saint Petersburg

200642

Spitalul Clinic Judetean de Urgenta Craiova, Craiova

400132

Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA, Cluj-Napoca

443095

"State Healthcare Institution Samara Regional Clinical Hospital n.a. M.I. Kalinin", Samara

454136

"Municipal Healthcare Institution City Clinical Hospital No. 3", Chelyabinsk

460000

"Municipal Healthcare Institution City Clinical Hospital No. 4", Orenburg

LV-3400

"Ltd Liepajas regionala slimnica", Liepāja

LV-1005

"Ltd Traumatologijas un ortopedijas slimnica", Riga

LV 4201

Vidzemes slimnica, Valmiera

85-094

Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narządu Ruchu, Bydgoszcz

31-826

Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddział Kliniczny Ortopedii i Traumatologii Narządu Ruchu, Krakow

15-276

Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii, Podlaski

20-090

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji, Trzemeszno Lubuskie

03-242

Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Chirurgii Urazowo-Ortopedycznej i Rehabilitacji, Warsaw

042122

Spitalul Clinic de Urgenta Sf. Ioan Bucuresti, Bucharest

Sponsors
All Listed Sponsors
collaborator

BioInvent International AB

INDUSTRY

collaborator

Covance

INDUSTRY

lead

ThromboGenics

INDUSTRY