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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.
Total knee replacement is an invasive surgical procedure that can expose patients to massive perioperative bleeding. This hematic loss results in a high rate of blood transfusion after total knee replacement (TKR) with an incidence from 10% to 58%.Methods to prevent the need for allogenic blood transfusion after TKR include hemodilution, perioperative blood salvage and reinfusion, hypotensive anesthesia, preoperative autologous blood donation and intravenous administration of tranexamic acid.
In the last decade, the topical use of fibrin sealant has become a logical surgical stratagem for reducing blood loss in total knee arthroplasty.Fibrin sealants mimic the final step of the coagulation cascade reducing blood loss and transfusion requirements.
A novel hemostatic agent derived from banked allogenic human plasma (EVICEL, Johnson & Johnson Wound Management, Ethicon, Somerville, NJ) is recently available on the market for a variety of surgical specialty.
A randomized controlled study is conducted to test if the post-operative reduction in hemoglobin level would be lower in the fibrin sealant group compared to a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evicel | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evicel | Drug | Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fall in post-operative hemoglobin level after total knee replacement | Hemoglobin values are collected in patients in first week post surgery to assess how these values have changed. | First 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| total blood loss | Calculation of perioperative blood loss is based on changes in hemoglobin (Hb) level. Assuming that the blood volume V0 on the seventh day after surgery is the same as that before surgery the loss of Hb is estimated according to the following formula: Hb-loss (g) =V0 (l)×(Hbpre-op (g/l)-Hb7day post-op(g/l))+Hb-transfused (g) where:
V0male(l)=0.3669×height(m)3+0.03219×weight(Kg)+0.6041 V0female(l)=0.3561×height(m)3+0.0338×weight(Kg)+0.1833 The total blood loss is calculated as follows: Blood loss(l)=Hb-loss(g)/Hbpre-op(g/l) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato | San Donato Milanese | Milano | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15174554 | 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. | |
| 21936146 | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| until 7 day after surgery |
| Blood Transfusion rate | Number of patients requiring 1 or more unit of allogenic banked blood | until 1 week after Surgery |
| 24674732 | Derived | 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. |
| D012216 |
| Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |