Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
DVT Osteoarthritis |
Drug: unfractionated heparin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
- DVT as determined by venography [ Time Frame: 5 day post op ] [ Designated as safety issue: No ]
- Bleeding rate Rate of PE Complication Rate [ Time Frame: 2 week post op ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | July 2003 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
-
Drug: unfractionated heparin
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00253851 History of Changes |
| Other Study ID Numbers: | OHREB 2002597-01H |
| Study First Received: | November 10, 2005 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ottawa Hospital Research Institute:
|
DVT Osteoarthritis Total Knee Arthroplasty |
Additional relevant MeSH terms:
|
Osteoarthritis Venous Thrombosis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Calcium heparin Heparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013