Status:
COMPLETED
Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
DVT
Osteoarthritis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
The goal of this study is to prevent blood clots from forming during surgery and a few days after total knee replacement surgery. This study will help us identify whether using a blood thinner in the ...
Detailed Description
Venous thromboembolism is a major cause of morbidity and mortality after lower limb orthopaedic surgery in the adult patient. If, as suggested, DVT formation begins intra-operatively then targeting th...
Eligibility Criteria
Inclusion
- Undergoing unilateral primary total knee arthroplasty
- Males and non-pregnant females ages 18-90 (pre-menopausal females will undergo a serum pregnancy test at screening)
- Full weight bearing status (of non-operated leg) following surgery
- Patient able to understand and willing to sign informed consent
Exclusion
- 1\) Known hypersensitivity to contrast media 2) Patients taking Metformin 3) Serum creatinine above 180Fmol/L 4) Platelets \< 100 x 10 9/L, INR/PTT \> 1.5 x normal 5) History of heparin induced thrombocytopenia 6) Allergy to heparin or fish 7) Prior use of protamine sulfate (i.e., protamine-containing insulin) 8) Vasectomized or infertile males 9) History of bleeding disorder 10) Bilateral total knee arthroplasty 11) History of stroke or myocardial infarction in previous 6 months 12) Traumatic spinal anaesthesia (two or more attempts and/or bloody) 13) History of previous DVT/PE 14) Active peptic ulcer disease (e.g., GI bleed, rectal bleed) 15) Currently on chronic anticoagulant therapy 16) Contra-indication to heparin 17) Patient is taking part in any other investigational study 18) Previous contralateral TKR or hip replacement
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00253851
Start Date
July 1 2003
End Date
June 1 2011
Last Update
April 17 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6