Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
NCT ID: NCT01344954
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
632 participants
INTERVENTIONAL
2011-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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25mg TB-402
TB-402
Administered intravenously over 10 minutes
50mg TB-402
TB-402
Administered intravenously over 10 minutes
10mg QD Rivaroxaban
Rivaroxaban
Administered orally as a capsule once a day for 35 days
Interventions
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TB-402
Administered intravenously over 10 minutes
Rivaroxaban
Administered orally as a capsule once a day for 35 days
TB-402
Administered intravenously over 10 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion Criteria
2. Indication for anticoagulation other than post-operative thromboprophylaxis.
3. Active bleeding or high risk of bleeding.
4. Anticipated continued use of neuraxial catheter after surgery.
5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
6. Uncontrolled hypertension.
7. Impaired liver function (transaminase \>3 X ULN) or history of hepatic insufficiency.
8. Creatinine clearance \<30 mL/min.
9. Antiplatelet agents other than low dose aspirin (\< 200mg).
10. The use of intermittent pneumatic compression.
11. Known hypersensitivity to contrast media or rivaroxaban.
12. Known drug or alcohol abuse.
13. Active malignant disease or current cytostatic treatment.
14. Stroke within the previous month.
15. Participation in an investigational drug study within the past 30 days or previous participation in this study.
16. Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.
18 Years
ALL
No
Sponsors
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BioInvent International AB
INDUSTRY
ThromboGenics
INDUSTRY
Responsible Party
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Locations
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KRANKENHAUS DES BARMHER.SCHW.Linz
Linz, , Austria
AKH Wien
Vienna, , Austria
Orthopädisches Spital Speising
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
ZNA Antwerpen Locatie Middelheim
Antwerp, , Belgium
SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
Pleven, , Bulgaria
Department of Orthopedics, UMHAT "Sv. Georgi"
Plovdiv, , Bulgaria
MHAT Rousse, Department of Orthopaedics
Rousse, , Bulgaria
UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology
Sofia, , Bulgaria
UMHAT 'Tsaritsa Joanna'
Sofia, , Bulgaria
Pándy Kálmán Kórház
Gyula, , Hungary
Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza
Kecskemét, , Hungary
Tolna Megyei Önkormányzat Balassa János Kórháza
Szekszárd, , Hungary
Traumatology and Orthopedics Clinic "Adazi", LTD
Ādaži, , Latvia
Ltd "Liepajas regionala slimnica"
Liepāja, , Latvia
Riga 2nd Hospital
Riga, , Latvia
Ltd "Vidzemes slimnica"
Valmiera, , Latvia
Diaconessenhuis Leiden
Leiden, , Netherlands
Klinika Orthopedii I Traumatologii
Bialystok, , Poland
Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi
Lodz, , Poland
NZOZ Szpital w Puszczykowie
Puszczykowo, , Poland
Klinika Ortopedii, WIM
Warsaw, , Poland
Medical University of warsaw, Dept of Orthopaedics
Warsaw, , Poland
Municipal Healthcare Institution "City Clinical Hospital No. 3"
Chelabinsk, , Russia
Municipal Healthcare Medical Institution "City Clinical Hospital No. 4"
Orenburg, , Russia
Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia
Saint Petersburg, , Russia
Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital"
Saint Petersburg, , Russia
Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
Saint Petersburg, , Russia
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
Samara, , Russia
Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov"
Yaroslavl, , Russia
Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology
Cherkassy, , Ukraine
Ivano-Frankіvsk Regional Clinical Hospital MoH Ukraine, Department of ortopedics and traumatology. Department of traumatology, ortopedics and military/emergency surgery of Ivano-Frankіvsk National Medical University
Ivano-Frankivsk, , Ukraine
SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement
Kharkiv, , Ukraine
Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital", Ortopedy and traumatology center of Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital"
Kyiv, , Ukraine
Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology.
Odesa, , Ukraine
Public Establishment 'City Hospital #9', orthopedy and traumatology department
Sevastopol, , Ukraine
Countries
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Other Identifiers
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TB-402-006
Identifier Type: -
Identifier Source: org_study_id