The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery|
- Fall in post-operative hemoglobin and hematocrit [ Time Frame: post operative day one and two ] [ Designated as safety issue: No ]Hemoglobin and hematocrit values will be collected in patients on day one and two post surgery to assess how these values have changed. We hope this product will decrease the drop in these values. We also hope that there will be a decrease in post operative transfusions and that patients will have better clinical outcomes.
- blood loss as measured by constavac drains [ Time Frame: 24 hours post insertion ] [ Designated as safety issue: No ]Patients will have two constavac drains inserted for 24 hours post surgery. The drain output will be measured at the end of the 24 hours. We hope this product will lead to less bleeding post operatively and therefore better clinical outcomes for patients.
- Pain Scores on the Visual Analog Scale [ Time Frame: pre operatively through six week post operatively ] [ Designated as safety issue: No ]Patients's scale of pain using a visual analogue will be accessed pre operatively, post operatively through day 2 and at six week post operatively. We hypothesize this product will lead to less inflammation, pain and therefore better clinical outcomes.
- The change in range of motion pre versus post operatively [ Time Frame: pre operatively through six weeks post operatively ] [ Designated as safety issue: No ]Patients passive range of motion will be recorded pre operatively, day 2 and at six weeks post operatively. We hope this product will decrease the time it takes for patients knee to return to standard range of motion
- Anti-coagulation effects on bleeding [ Time Frame: pre operatively and post operative day 2 ] [ Designated as safety issue: No ]All patients will take coumadin for deep vein thrombosis prophylaxis as part of the standard of care for the two surgeons involved in this study. Because of this, we will record INR levels pre-operatively and on POD #2. This will act as an important control to ensure minimization of confounding effects of anti-coagulation on bleeding.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Evicel
Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
Drug: Evicel fibrin sealant
Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.
No Intervention: no evicel
Patients will receive standard treatment for bleeding as practiced at HSS.
No additional data desired
|Contact: Mark P Figgie, M.Demail@example.com|
|Contact: Denise M Drinkwater, B.Afirstname.lastname@example.org|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Denise Drinkwater 646-797-8940 email@example.com|
|Principal Investigator: Mark Figgie, M.D|
|Sub-Investigator: Steven Haas, M.D|
|Sub-Investigator: Han Jo Kim, M.D|
|Sub-Investigator: Barbara Kahn, R.N.|
|Sub-Investigator: Denise Drinkwater, B.A.|
|Principal Investigator:||Mark P Figgie, M.D||Hospital for Special Surgery, New York|