Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery

Phase 4

Completed

• Conditions: DVT; Osteoarthritis

• Registration Number: NCT00253851
• Lead Sponsor: Ottawa Hospital Research Institute

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 operating room will stop blood clots from forming during the operation.

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 this period to prevent clot formation could substantially reduce DVT rates in the TKA population. The present study aims to determine whether this intra-operative regional heparinization technique is effective in preventing the intra-operative formation of DVT following TKA, as evidenced by venography in the early post-operative period.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Undergoing unilateral primary total knee arthroplasty
2. Males and non-pregnant females ages 18-90 (pre-menopausal females will undergo a serum pregnancy test at screening)
3. Full weight bearing status (of non-operated leg) following surgery
4. Patient able to understand and willing to sign informed consent

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DVT as determined by venography	5 day post op

Secondary Outcome Measures

Name	Time	Method
Bleeding rate Rate of PE Complication Rate	2 week post op

Trial Locations

Locations (1)

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada