The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement

Osteoarthritis of the Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816282
• Other study ID #: Bleeding Control
• Status: Completed
• Phase: N/A
• First received: March 15, 2013
• Last updated: March 22, 2013
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient scheduled for TKR

• written informed consent

• diagnosis of osteoarthritis

Exclusion Criteria:

• previous intervention on the same Knee (except for meniscectomy)

• Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman

• Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee
• Primary Knee Arthroplasty
• Total Knee Replacement

Intervention

Drug:
• Evicel
Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure

Locations

Country	Name	City	State
Italy	Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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: Hb-loss (g) is the amount of hemoglobin lost; Hbpre-op (g/l) is the hemoglobin level before surgery; Hb7day post-op (g/l) is the hemoglobin level in postoperative day 7; Hb-transfused (g) is the total amount of allogeneic hemoglobin transfused; a unit of banked blood is considered to contain 52 g of hemoglobin.; V0 (l) is the total blood volume of patient and it is calculated using the formula of Nadler: 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)	until 7 day after surgery	No
Secondary	Blood Transfusion rate	Number of patients requiring 1 or more unit of allogenic banked blood	until 1 week after Surgery	No