A clinical study to assess the safety and efficacy of TB-402 for the prevention of formation of blood clots in the legs or lungs after hip replacement surgery.

• Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]; Venous Thromboembolic Event; MedDRA version: 14.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2010-023383-40-BG
• Lead Sponsor: ThromboGenics N.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-24
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Male or female subjects aged = 18 years old scheduled for elective total hip replacement surgery.
2. Written informed consent.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600
;
1. Male or female subjects aged = 18 years old scheduled for elective total hip replacement surgery.
2. Written informed consent.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

1. Pregnancy at the time of screening based on a urine or blood pregnancy test or not using a reliable method of birth control.
2. Indication for anticoagulation other than post-operative thromboprophylaxis.
3. Active bleeding or high risk of bleeding contraindicating anticoagulant treatment according to the investigator.
4. Anticipated continued use of neuraxial catheter after surgery.
5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT such that anticoagulation is contraindicated according to the investigator
6. Uncontrolled hypertension according to the investigator.
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 (< 200 mg).
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.

;
1. Pregnancy at the time of screening based on a urine or blood pregnancy test or not using a reliable method of birth control.
2. Indication for anticoagulation other than post-operative thromboprophylaxis.
3. Active bleeding or high risk of bleeding contraindicating anticoagulant treatment according to the investigator.
4. Anticipated continued use of neuraxial catheter after surgery.
5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT such that anticoagulation is contraindicated according to the investigator
6. Uncontrolled hypertension according to the investigator.
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 (< 200 mg).
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified