drugset / Trial / NCT01816282
The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement
RandomizedParallel-groupSingle-blindTreatment
Summary
A randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, Evicel (Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. We hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.
Timeline
- Start
- 2011-03
- Primary completion
- 2012-04
- Completion
- 2012-06
Publications
- Background Sehat KR, Evans RL, Newman JH. Hidden blood loss following hip and knee arthroplasty. Correct management of blood loss should take hidden loss into account. J Bone Joint Surg Br. 2004 May;86(4):561-5.
- Background Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
- Randelli F, D'Anchise R, Ragone V, Serrao L, Cabitza P, Randelli P. Is the newest fibrin sealant an effective strategy to reduce blood loss after total knee arthroplasty? A randomized controlled study. J Arthroplasty. 2014 Aug;29(8):1516-20. doi: 10.1016/j.arth.2014.02.024. Epub 2014 Feb 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 5 ml | Topical |