Back to resultsDoes Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery
Primary Purpose
DVT, Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
unfractionated heparin
Sponsored by
About this trial
This is an interventional prevention trial for DVT focused on measuring DVT, Osteoarthritis, Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria: 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 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
Sites / Locations
- Ottawa Hospital
Outcomes
Primary Outcome Measures
DVT as determined by venography
Secondary Outcome Measures
Bleeding rate Rate of PE Complication Rate
Full Information
NCT ID
NCT00253851
First Posted
November 10, 2005
Last Updated
April 13, 2012
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00253851
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DVT, Osteoarthritis
Keywords
DVT, Osteoarthritis, Total Knee Arthroplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
unfractionated heparin
Intervention Description
Five minutes prior to tourniquet inflation, patients will receive 0.1 ml/kg/minute of intravenous (IV) unfractionated heparin (1000 units/ml) or placebo (normal saline solution). Five minutes will be allowed to elapse to ensure complete systemic heparinization. The operated limb will then be elevated and exsanguinated using an Esmarch bandage. Following cuff inflation, the contents of a second syringe will be administered IV over a 5 minute period. The second syringe will contain either protamine sulfate (1.0 mg/kg) to reverse the systemic heparin for patients in the treatment group, or normal saline for the control group. Study drugs will be administered by the anaesthesiologist via a peripheral IV. This new method of intraoperative regional heparinization has been used in two previous studies (Giachino et al., 2001; Giachino et al., 1985) with no adverse effects noted.
Primary Outcome Measure Information:
Title
DVT as determined by venography
Time Frame
5 day post op
Secondary Outcome Measure Information:
Title
Bleeding rate Rate of PE Complication Rate
Time Frame
2 week post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Giachino
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
12. IPD Sharing Statement
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Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery
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