Venous thromboembolism following total hip arthoplasty Circulatory System Venous thromboembolism
Conditions
Interventions
Current interventions as of 05/12/2007:
1. Aspirin: 81 mg once a day for 28 days
2. Dalteparin: 5000 i.u. subcutaneously once a day
3. Matching placebo (aspirin): one pill once a day for 28 days
4. Ma
Sponsors
Dalhousie University (Canada) - Research Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing elective total hip arthroplasty at the participating institutions 2. Age 18 years and older, either sex. However, please note that if a patient under 18 years presents to the clinic (although this is unlikely), they will be included.
Exclusion criteria
Exclusion criteria: Added as of 25/02/2009: 15. Investigator decision 16. Bilateral total hip arthroplasty (THA) or simultaneous hip and knee surgery 17. Unable to give consent 18. Geographical inaccessibility 19. Requirement for major surgery within 28 day study-drug period Amended as of 05/12/2007: 1. Hip fracture in the previous three months 2. Metastatic cancer 3. Life expectancy less than 6 months 4. History of major bleeding that, in the judgement of the investigator, precludes use of anticoagulant prophylaxis 5. History of aspirin allergy, active peptic ulcer disease or gastritis that, in the judgment of the investigator, precludes use of aspirin 6. History of heparin induced thrombocytopenia or heparin allergy 7. Creatine clearance less than 30 ml per minute 8. Platelet count less than 100 x 10^9/L 9. Need for long-term anticoagulation due to pre-existing co-morbid conditions or due to the development of venous thromboembolism following surgery but prior to randomisation 10. Need for aspirin over the course of the study due to pre-existing co-morbid condition 11. Previous participation in this study 12. Refusal to give informed consent 13. Did not, or will not, receive dalteparin post-operatively for Venous Thromboembolism (VTE) prophylaxis 14. Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period Initial information at time of registration: 1. Hip fracture in the previous three months 2. Metastatic cancer 3. Life expectancy less than 6 months 4. History of major bleeding that, in the judgement of the investigator, precludes use of anticoagulant prophylaxis 5. History of aspirin allergy, active peptic ulcer disease or gastritis that, in the judgment of the investigator, precludes use of aspirin 6. History of heparin induced thrombocytopenia or heparin allergy 7. Chonic renal failure (creatine clearance less than 30 ml per minute) 8. Platelet count less than 100 x 10^9/L 9. Need for long-term anticoagulation due to pre-existing co-morbid conditions or due to the development of venous thromboembolism following surgery but prior to randomisation 10. Need for aspirin over the course of the study due to pre-existing co-morbid condition 11. Previous participation in this study 12. Geographic inaccessibility for follow-up 13. Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/01/2008: Venous thromboembolism (pulmonary embolism of deep vein thrombosis), assessed at 90 days. Previous primary outcome measures: 1. Symptomatic venous thromboembolic complications, assessed at 90 days 2. Venous thromboembolism (pulmonary embolism of deep vein thrombosis), assessed at 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/01/2008: 1. Survival, assessed at 90 days 2. Major bleeding, assessed at 90 days 3. Wound infection, assessed at 90 days 4. Stroke, assessed at 90 days 5. Thrombocytopenia, assessed at 90 days 6. Cost effectiveness, assessed at 90 days Previous secondary outcome measures: 1. Survival, assessed at 90 days 2. Major bleeding, assessed at 90 days 3. Myocardial infarction, assessed at 90 days 4. Stroke, assessed at 90 days 5. Cost effectiveness, assessed at 90 days | — |
Countries
Canada
Outcome results
None listed