Clinical trial NCT01225822: BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
Official title: BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 1973
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.


Eligibility criteria: Inclusion criteria

1. Patients scheduled to undergo a primary elective total hip or knee replacement.
2. Male of female being 18 years or older.
3. Patients weighing at least 40 kg.
4. Written informed consent for study participation.

Exclusion criteria

1. Bleeding diathesis, constitutional or acquired coagulation disorders.
2. Major surgery or trauma(e.g., hip fracture) within the last 3 months.
3. Cardiovascular disease
4. Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings.
5. Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year.
6. History of or acute intracranial disease
7. Liver disease
8. Renal disease
9. Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation.
10. Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control
11. Known allergy to contrast media
12. Thrombocytopenia
13. Allergy against heparin.
14. Active malignant disease or current cytostatic treatment.
15. Treatment with an investigational drug in the past month.
16. Leg amputee
17. Known alcohol or drug abuse

Primary outcomes:
measure: Number of Participants With Venous Thromboembolic (VTE) Events
timeFrame: Treatment period (up to day 8+/-2 days visit)
measure: Number of Participants With Major Bleeding Events (MBE)
timeFrame: From approximately 14 days prior to surgery to 4-6 weeks post surgery
Secondary outcomes:
measure: Number of Participants With VTE Events and All Cause Mortality
timeFrame: Treatment period (up to day 8+/-2 days visit)
measure: Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality
timeFrame: Treatment period (up to day 10)
measure: Number of Participants With Proximal DVT
timeFrame: Treatment period (up to day 8+/-2 days visit)
measure: Volume of Blood Loss
timeFrame: Day 1 (Day of surgery)
measure: Rate of Transfusions Due to Bleedings
timeFrame: Day 1 (Day of surgery)
measure: Number of Participants With Clinically Significant, Minor or Any Bleeding Events
timeFrame: Treatment period (up to day 8+/-2 days visit)
measure: Laboratory Analyses
timeFrame: Screening to end of treatment
measure: Plasma Concentration (Cmax) of Dabigatran
timeFrame: Day 1 to end of treatment
measure: Area Under the Plasma Concentration-time Curve During a Dosing Interval
timeFrame: up to day 8+/-2 days visit
Other outcomes:
Locations:
city: Linz
country: Austria
facility: 1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz
city: Wien
country: Austria
facility: 1160.19.43002 Orthopädisches Spital Speising
city: Wr. Neustadt
country: Austria
facility: 1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt
city: Brussel
country: Belgium
facility: 1160.19.32002 V.U.B. Jette
city: Gent
country: Belgium
facility: 1160.19.32004 UZ Gent
city: Gent
country: Belgium
facility: 1160.19.32005 Virga Jesseziekenhuis
city: Huy
country: Belgium
facility: 1160.19.32006 Boehringer Ingelheim Investigational Site
city: La Louvière
country: Belgium
facility: 1160.19.32007 C.H.U. de Tivoli
city: Brno-Bohunice
country: Czech Republic
facility: 1160.19.42004 University Hospital Brno
city: Kladno
country: Czech Republic
facility: 1160.19.42001 Hospital Kladno
city: Mlada Boleslav
country: Czech Republic
facility: 1160.19.42006 Hospital Mlada Boleslav
city: Ostrava
country: Czech Republic
facility: 1160.19.42003 University Hospital Ostrava
city: Plzen
country: Czech Republic
facility: 1160.19.42005 University Hospital Plzen
city: Prague 8
country: Czech Republic
facility: 1160.19.42009 University Hospital Na Bulovce
city: Frederiksberg
country: Denmark
facility: 1160.19.45042 Orthopedic Surgical Clinic
city: Hellerup
country: Denmark
facility: 1160.19.45045 Gentofte Hospital
city: Herlev
country: Denmark
facility: 1160.19.45043 Herlev Hospital
city: Hørsholm
country: Denmark
facility: 1160.19.45041 Hørsholm Sygehus
city: Silkeborg
country: Denmark
facility: 1160.19.45044 Orthopedic Surgical Dept.
city: Jyväskylä
country: Finland
facility: 1160.19.35802 Keski-Suomen keskussairaala
city: Oulu
country: Finland
facility: 1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.
city: Illkirch cedex
country: France
facility: 1160.19.33004 Div
city: La Rochelle
country: France
facility: 1160.19.33007 Clinique du Mail
city: Lyon cedex 03
country: France
facility: 1160.19.33009 Hôpital Edouard Herriot
city: Saint-Etienne cedex 2
country: France
facility: 1160.19.33006 Clinique Mutualiste
city: St Herblain cedex
country: France
facility: 1160.19.33008 Clinique de l'Atlantique
city: Budapest
country: Hungary
facility: 1160.19.36003 Sándor Péterfy Hospital
city: Gyula
country: Hungary
facility: 1160.19.36001 Kálmán Pándy County Hospital
city: Kecskemét
country: Hungary
facility: 1160.19.36004 Bács-Kiskun County Hospital
city: Szeged
country: Hungary
facility: 1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center
city: Székesfehérvár
country: Hungary
facility: 1160.19.36005 Szent György Hospital
city: Bergamo
country: Italy
facility: 1160.19.39003 U. O. Ortopedia e Traumatologia
city: Bologna
country: Italy
facility: 1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia
city: Milano
country: Italy
facility: 1160.19.39002 Fondazione Centro S. Raffaele
city: Pavia
country: Italy
facility: 1160.19.39001 IRCCS Policlinico San Matteo
city: Varese
country: Italy
facility: 1160.19.39004 Ospedale di Circolo di Varese
city: Amsterdam
country: Netherlands
facility: 1160.19.31001 Boehringer Ingelheim Investigational Site
city: Hilversum
country: Netherlands
facility: 1160.19.31003 Boehringer Ingelheim Investigational Site
city: Nijmegen
country: Netherlands
facility: 1160.19.31005 Hengstdal 3
city: Sittard
country: Netherlands
facility: 1160.19.31006 Boehringer Ingelheim Investigational Site
city: Zwolle
country: Netherlands
facility: 1160.19.31004 Boehringer Ingelheim Investigational Site
city: Bodø
country: Norway
facility: 1160.19.47001 Nordlandssykehuset HF, Bodø
city: Bærum Postterminal
country: Norway
facility: 1160.19.47004 Martina Hansens Hospital
city: Bærum Postterminal
country: Norway
facility: 1160.19.47008 Martina Hansens Hospital
city: Elverum
country: Norway
facility: 1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum
city: Haugesund
country: Norway
facility: 1160.19.47005 Haugesund sjukehus HF
city: Skien
country: Norway
facility: 1160.19.47002 Sykehuset Telemark HF, Avd. Skien
city: Ålesund
country: Norway
facility: 1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus
city: Johannesburg
country: South Africa
facility: 1160.19.27001 Dept. of Haematology
city: Johannesburg
country: South Africa
facility: 1160.19.27002 Suite 203
city: Falköping
country: Sweden
facility: 1160.19.46002 Kirurgavdelningen
city: Göteborg
country: Sweden
facility: 1160.19.46001
city: Halmstad
country: Sweden
facility: 1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad
city: Kalmar
country: Sweden
facility: 1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar
city: Kungälvs
country: Sweden
facility: 1160.19.46007 Kungälvs sjukhus
city: Lidköping
country: Sweden
facility: 1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping
city: Linköping
country: Sweden
facility: 1160.19.46008 Ortopediska Institutionen
city: Mölndal
country: Sweden
facility: 1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal
city: Varberg
country: Sweden
facility: 1160.19.46006 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: