Clinical trial NCT00253851: Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery
Official title: Multi-centre, Double-blind, Randomized, Controlled Trial Comparing Intra-operative Regional Heparinization to Placebo for the Prevention of Deep Vein Thrombosis Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: DVT
Osteoarthritis
Keywords: DVT
Osteoarthritis
Total Knee Arthroplasty
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2005-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Exclusion Criteria:

* 1) Known hypersensitivity to contrast media 2) Patients taking Metformin 3) Serum creatinine above 180Fmol/L 4) Platelets \&lt; 100 x 10 9/L, INR/PTT \&gt; 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

Primary outcomes:
measure: DVT as determined by venography
timeFrame: 5 day post op
Secondary outcomes:
measure: Bleeding rate Rate of PE Complication Rate
timeFrame: 2 week post op
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: A Giachino
role: PRINCIPAL_INVESTIGATOR
References: