Clinical trial NCT01344954: Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
Official title: Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prophylaxis of Venous Thromboembolic Events
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
Collaborators: name: BioInvent International AB
First posted: 2011-04-29
Enrollment: 632
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 purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥ 18 years.
2. Written informed consent.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

1. Pregnancy at the time of screening.
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.

Primary outcomes:
measure: Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE
timeFrame: Randomisation to post-operative day 35
Secondary outcomes:
measure: Incidents of major VTE
timeFrame: Randomisation to Post-Operative day 35
measure: Incidents of total DVT
timeFrame: Randomisation to Post-Operative day 35
measure: Incidents of proximal/distal DVT
timeFrame: Randomisation to Post-Operative day 35
measure: Incidents of pulmonary embolism
timeFrame: Randomisation to Post-Operative day 35
measure: Incidents of VTE-related death
timeFrame: Randomisation to Post-Operative day 35
measure: Incidents of Major VTE
timeFrame: Randomisation to Post-Operative day 70
Other outcomes:
Locations:
city: Linz
country: Austria
facility: KRANKENHAUS DES BARMHER.SCHW.Linz
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Orthopädisches Spital Speising
city: Antwerpen
country: Belgium
facility: ZNA Antwerpen Locatie Middelheim
city: Pleven
country: Bulgaria
facility: SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
city: Plovdiv
country: Bulgaria
facility: Department of Orthopedics, UMHAT "Sv. Georgi"
city: Rousse
country: Bulgaria
facility: MHAT Rousse, Department of Orthopaedics
city: Sofia
country: Bulgaria
facility: UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Joanna'
city: Gyula
country: Hungary
facility: Pándy Kálmán Kórház
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza
city: Szekszárd
country: Hungary
facility: Tolna Megyei Önkormányzat Balassa János Kórháza
city: Adazi
country: Latvia
facility: Traumatology and Orthopedics Clinic "Adazi", LTD
city: Liepāja
country: Latvia
facility: Ltd "Liepajas regionala slimnica"
city: Riga
country: Latvia
facility: Riga 2nd Hospital
city: Valmiera
country: Latvia
facility: Ltd "Vidzemes slimnica"
city: Leiden
country: Netherlands
facility: Diaconessenhuis Leiden
city: Bialystok
country: Poland
facility: Klinika Orthopedii I Traumatologii
city: Puszczykowo
country: Poland
facility: NZOZ Szpital w Puszczykowie
city: Warsaw
country: Poland
facility: Medical University of warsaw, Dept of Orthopaedics
city: Warszawa
country: Poland
facility: Klinika Ortopedii, WIM
city: Łódź
country: Poland
facility: Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi
city: Chelabinsk
country: Russian Federation
facility: Municipal Healthcare Institution "City Clinical Hospital No. 3"
city: Orenburg
country: Russian Federation
facility: Municipal Healthcare Medical Institution "City Clinical Hospital No. 4"
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital"
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
city: Samara
country: Russian Federation
facility: State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
city: Yaroslavl
country: Russian Federation
facility: Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov"
city: Cherkassy
country: Ukraine
facility: Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology
city: Ivano-Frankivsk
country: Ukraine
facility: 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
city: Kharkiv
country: Ukraine
facility: SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement
city: Kyiv
country: Ukraine
facility: 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"
city: Odessa
country: Ukraine
facility: Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology.
city: Sevastopol
country: Ukraine
facility: Public Establishment 'City Hospital #9', orthopedy and traumatology department
Study officials:
References: