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