OsteoarthritisPhase 4NCT01235715

The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

A Phase 4 study testing Evicel fibrin sealant in people with Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin. Read more about this study

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Osteoarthritis
What is being tested?: Evicel fibrin sealant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Sep 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty

Who cannot join

Known allergies to human blood products.
History of bleeding disorders.
Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.
Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)
Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Read the detailed description

No additional data desired

Conditions: Osteoarthritis
Being tested: Evicel fibrin sealant
Keywords: osteoarthritis, total knee replacement
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evicel fibrin sealantDrug
Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.

Study groups in NCT01235715
Study group	Role	What they receive
Evicel	Active comparator	Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent. Receives: Drug: Evicel fibrin sealant
no evicel	No intervention	Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hemoglobin on Day 0 Compared to Preoperatively
Measured: preoperatively and on the day of surgery
Change in Hematocrit on Day 0 Compared to Preoperatively
Measured: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
Measured: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
Measured: preoperatively and one day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
Measured: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
Measured: preoperatively and two days after surgery
Drain Output
A measurement of the amount of blood drained from the knee.
Measured: 24 hours post-operatively
Number of Autologous Transfusion Units Over the Course of the Hospital Stay
Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Measured: perioperatively
Units of Homologous Transfusion Over the Course of the Hospital Stay
Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Measured: three days postoperatively

Secondary outcomes (8)

Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively
The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.
Measured: preoperatively and two days after surgery
Range of Motion on Day 3
A measurement of the degrees of motion of the operated knee three days after surgery.
Measured: 3 days postoperatively
Visual Analog Pain Scale on Day 3
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.
Measured: 3 days postoperatively
Range of Motion at 6 Weeks
A measurement of the degrees of motion of the operated knee six weeks after surgery.
Measured: 6 weeks postoperatively
Visual Analog Pain Scale (at Rest) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.
Measured: 6 weeks postoperatively
Visual Analog Pain Scale (During Activity) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.
Measured: 6 weeks postoperatively
Visual Analog Pain Scale (During Therapy) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.
Measured: 6 weeks postoperatively
Visual Analog Pain Scale (At Night) At 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.
Measured: 6 weeks postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Sep 2012

First posted5 Nov 2010 (estimated)
Study startSep 2010
Primary completionMar 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01235715
Sponsor's protocol ID: 29054
Status last verified: Aug 2013
First submitted: 8 Oct 2010
Last updated: 29 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
ClinicalTrials.gov ID: NCT01235715
Acronym / sponsor ID: 29054
Conditions: Osteoarthritis
Keywords: osteoarthritis, total knee replacement
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Collaborators: Ethicon, Inc.
Study start: Sep 2010
Primary completion: Mar 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 5 Nov 2010 (estimated)
Results: Posted 29 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

No additional data desired

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Evicel	Active comparator	Drug: Evicel fibrin sealantEvicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
no evicel	No intervention	–Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty

Key exclusion criteria (5 listed)

Known allergies to human blood products.
History of bleeding disorders.
Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.
Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)
Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.

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
Evicel fibrin sealantUsed for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.	Drug	Evicel

Primary outcome

Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: preoperatively and on the day of surgery
Change in Hematocrit on Day 0 Compared to Preoperatively
Time frame: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Drain Output
Time frame: 24 hours post-operatively
A measurement of the amount of blood drained from the knee.
Number of Autologous Transfusion Units Over the Course of the Hospital Stay
Time frame: perioperatively
Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Units of Homologous Transfusion Over the Course of the Hospital Stay
Time frame: three days postoperatively
Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

8 secondary outcomes

Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Range of Motion on Day 3
Time frame: 3 days postoperatively
Visual Analog Pain Scale on Day 3
Time frame: 3 days postoperatively
Range of Motion at 6 Weeks
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (at Rest) at 6 Weeks
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (During Activity) at 6 Weeks
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (During Therapy) at 6 Weeks
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (At Night) At 6 Weeks
Time frame: 6 weeks postoperatively

Results and safety

Results posted to the registry on 29 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evicel	98	98
No Evicel	102	100

Primary outcome: Change in Hemoglobin on Day 0 Compared to Preoperatively

Time frame: preoperatively and on the day of surgery. Mean (Standard Deviation). Unit: g/dL

Measure	Evicel n = 95	No Evicel n = 96
Value	-1.548 (.745)	-1.458 (.815)

Population analysed: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.

Primary outcome: Change in Hematocrit on Day 0 Compared to Preoperatively

Time frame: preoperatively and day of surgery. Mean (Standard Error). Unit: percentage of red blood cell

Measure	Evicel n = 94	No Evicel n = 96
Value	-4.639 (2.275)	-4.220 (2.537)

Population analysed: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.

Primary outcome: Change in Hemoglobin On Day 1 Compared to Preoperatively

Time frame: preoperatively and one day after surgery. Mean (Standard Deviation). Unit: g/dL

Measure	Evicel n = 95	No Evicel n = 99
Value	-2.607 (0.986)	-2.480 (1.063)

Population analysed: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.

Primary outcome: Change in Hematocrit on Day 1 Compared to Preoperatively

Time frame: preoperatively and one day after surgery. Mean (Standard Deviation). Unit: percentage of red blood cell

Measure	Evicel n = 94	No Evicel n = 99
Value	-7.382 (2.801)	-7.199 (3.381)

Population analysed: All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evicel	0 of 98 (0%)	28 of 98 (28.6%)	Not reported
no Evicel	0 of 102 (0%)	17 of 102 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Ethicon websiteLink provided by the sponsor.

Related trials for Osteoarthritis

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Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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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.

Mark P Figgie, M.D principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Evicel fibrin sealant in people with Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.

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 1 inclusion and 5 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 29 Oct 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Hemoglobin on Day 0 Compared to Preoperatively (time frame: preoperatively and on the day of surgery). The study lists 9 primary outcomes in all. 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 NCT01235715.

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 29 Oct 2013.