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

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.

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Key information

Conditions

Total Knee Replacement Arthritis Hemorrhage Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis of the Knee Osteoarthritis, Knee Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Knee Arthroplasty Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato

San Donato Milanese, Milano, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVICEL

Drug

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

Primary outcomes

Fall in post-operative hemoglobin level after total knee replacement

Time frame: First 7 days after surgery

Hemoglobin values are collected in patients in first week post surgery to assess how these values have changed.

Secondary outcomes

total blood loss

Time frame: until 7 day after surgery
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)
Blood Transfusion rate

Time frame: until 1 week after Surgery

Number of patients requiring 1 or more unit of allogenic banked blood

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Mar 22, 2013
Registry last updated: Mar 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed