Total Knee ReplacementNCT01816282
The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement
A study testing Evicel in people with Total Knee Replacement and Primary Knee Arthroplasty, run by University of Milan at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Replacement, Primary Knee Arthroplasty, Osteoarthritis of the Knee
- What is being tested?
- Evicel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient scheduled for TKR
- written informed consent
- diagnosis of osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato
San Donato Milanese, Milano
About this study
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.
Read the detailed 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.
- Being tested
- Evicel
- Keywords
- TKR, Blood loss, Fibrin Sealant
- Medical subject headings
- Osteoarthritis, Knee, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvicelDrug
Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure
| Study group | Role | What they receive |
|---|---|---|
| Evicel | Experimental | Not described Receives: Drug: Evicel |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 7 days after surgery
Secondary outcomes (2)
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)
Measured: until 7 day after surgery
Blood Transfusion rate
Number of patients requiring 1 or more unit of allogenic banked blood
Measured: until 1 week after Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Randelli, MD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816282
- Sponsor's protocol ID
- Bleeding Control
- Status last verified
- Mar 2013
- First submitted
- 15 Mar 2013
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15174554Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
PubMed 21936146Randelli 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.
PubMed 24674732
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01816282
- Acronym / sponsor ID
- Bleeding Control
- Keywords
- TKR, Blood loss, Fibrin Sealant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evicel | Experimental | Drug: Evicel |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patient scheduled for TKR
- written informed consent
- diagnosis of osteoarthritis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvicelEvicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure | Drug | Evicel |
Primary outcome
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.
2 secondary outcomes
total blood loss
Time frame: until 7 day after surgery
Blood Transfusion rate
Time frame: until 1 week after Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
- Background: PubMed 15174554Sehat 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: PubMed 21936146Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
- Derived from this study: PubMed 24674732Randelli 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.
Related trials for Total Knee Replacement
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evicel in people with Total Knee Replacement and Primary Knee Arthroplasty, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall in post-operative hemoglobin level after total knee replacement (time frame: First 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816282, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.