The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement
1 other identifier
interventional
62
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedMarch 25, 2013
March 1, 2013
1.1 years
March 15, 2013
March 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
total blood loss
until 7 day after surgery
Blood Transfusion rate
until 1 week after Surgery
Study Arms (2)
Evicel
EXPERIMENTALControl
NO INTERVENTIONInterventions
Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure
Eligibility Criteria
You may qualify if:
- patient scheduled for TKR
- written informed consent
- diagnosis of osteoarthritis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato
San Donato Milanese, Milano, Italy
Related Publications (3)
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.
PMID: 15174554BACKGROUNDNadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
PMID: 21936146BACKGROUNDRandelli 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.
PMID: 24674732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 15, 2013
First Posted
March 22, 2013
Study Start
March 1, 2011
Primary Completion
April 1, 2012
Study Completion
June 1, 2012
Last Updated
March 25, 2013
Record last verified: 2013-03