Trial Outcomes & Findings for The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery (NCT NCT01235715)

NCT ID: NCT01235715

Last Updated: 2013-10-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 200 participants
• Primary outcome timeframe: preoperatively and on the day of surgery
• Results posted on: 2013-10-29

Participant Flow

Patients undergoing total knee arthroplasty at the Hospital for Special Surgery from September 2010 to June 2012 were enrolled in a consecutive prospective manner on a voluntary basis.

Participant milestones

Measure	Evicel 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.	No Evicel Patients will receive standard treatment for bleeding as practiced at HSS.
Overall Study STARTED	98	102
Overall Study COMPLETED	98	100
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Evicel 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.	No Evicel Patients will receive standard treatment for bleeding as practiced at HSS.
Overall Study Physician Decision	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Evicel n=98 Participants 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.	no Evicel n=102 Participants Patients will receive standard treatment for bleeding as practiced at HSS.	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	41 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	64 Participants n=5 Participants	61 Participants n=7 Participants	125 Participants n=5 Participants
Age Continuous	68.12 years STANDARD_DEVIATION 9.88 • n=5 Participants	66.38 years STANDARD_DEVIATION 8.47 • n=7 Participants	67 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	59 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	102 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: preoperatively and on the day of surgery

Population: 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.

Outcome measures

Measure	Evicel n=95 Participants 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.	No Evicel n=96 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Change in Hemoglobin on Day 0 Compared to Preoperatively	-1.548 g/dL Standard Deviation .745	-1.458 g/dL Standard Deviation .815

PRIMARY outcome

Timeframe: preoperatively and day of surgery

Population: 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.

Outcome measures

Measure	Evicel n=94 Participants 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.	No Evicel n=96 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Change in Hematocrit on Day 0 Compared to Preoperatively	-4.639 percentage of red blood cell Standard Error 2.275	-4.220 percentage of red blood cell Standard Error 2.537

PRIMARY outcome

Timeframe: preoperatively and one day after surgery

Population: 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.

Outcome measures

Measure	Evicel n=95 Participants 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.	No Evicel n=99 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Change in Hemoglobin On Day 1 Compared to Preoperatively	-2.607 g/dL Standard Deviation 0.986	-2.480 g/dL Standard Deviation 1.063

PRIMARY outcome

Timeframe: preoperatively and one day after surgery

Population: 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.

Outcome measures

Measure	Evicel n=94 Participants 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.	No Evicel n=99 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Change in Hematocrit on Day 1 Compared to Preoperatively	-7.382 percentage of red blood cell Standard Deviation 2.801	-7.199 percentage of red blood cell Standard Deviation 3.381

PRIMARY outcome

Timeframe: preoperatively and two days after surgery

Population: 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.

Outcome measures

Measure	Evicel n=94 Participants 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.	No Evicel n=98 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Change in Hemoglobin on Day 2 Compared to Preoperatively	-3.419 g/dL Standard Deviation 1.437	-3.497 g/dL Standard Deviation 1.157

PRIMARY outcome

Timeframe: preoperatively and two days after surgery

Population: 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.

Outcome measures

Measure	Evicel n=93 Participants 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.	No Evicel n=98 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Change in Hematocrit on Day 2 Compared to Preoperatively	-9.676 percentage of red blood cell Standard Deviation 4.540	-10.100 percentage of red blood cell Standard Deviation 3.597

PRIMARY outcome

Timeframe: 24 hours post-operatively

Population: 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

A measurement of the amount of blood drained from the knee.

Outcome measures

Measure	Evicel n=98 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Drain Output	780 mL Standard Error 54.23	673 mL Standard Error 54.23

PRIMARY outcome

Timeframe: perioperatively

Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

Outcome measures

Measure	Evicel n=98 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Number of Autologous Transfusion Units Over the Course of the Hospital Stay	0.38 units Standard Error 0.041	0.46 units Standard Error 0.041

PRIMARY outcome

Timeframe: three days postoperatively

Population: All patients who completed the study were included in analysis.

Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

Outcome measures

Measure	Evicel n=98 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Units of Homologous Transfusion Over the Course of the Hospital Stay	0.276 units Standard Deviation 0.729	0.228 units Standard Deviation 0.581

SECONDARY outcome

Timeframe: preoperatively and two days after surgery

Population: All patients who completed the study were included in analysis.

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.

Outcome measures

Measure	Evicel n=98 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively	.363 ratio Standard Deviation .421	0.309 ratio Standard Deviation 0.514

SECONDARY outcome

Timeframe: 3 days postoperatively

A measurement of the degrees of motion of the operated knee three days after surgery.

Outcome measures

Measure	Evicel n=98 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Range of Motion on Day 3	112.4 degrees Standard Error 1.983	114.1 degrees Standard Error 1.983

SECONDARY outcome

Timeframe: 3 days postoperatively

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.

Outcome measures

Measure	Evicel n=98 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Visual Analog Pain Scale on Day 3	4.3 points on VAS scale Standard Error 1.983	3.9 points on VAS scale Standard Error 1.983

SECONDARY outcome

Timeframe: 6 weeks postoperatively

Population: Patients whose range of motion at 6-week followup appointment was taken were included in analysis.

A measurement of the degrees of motion of the operated knee six weeks after surgery.

Outcome measures

Measure	Evicel n=96 Participants 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.	No Evicel n=98 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Range of Motion at 6 Weeks	114 degrees Standard Deviation 10.8	115 degrees Standard Deviation 12.4

SECONDARY outcome

Timeframe: 6 weeks postoperatively

Population: Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.

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.

Outcome measures

Measure	Evicel n=95 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Visual Analog Pain Scale (at Rest) at 6 Weeks	1.326 units on a scale Standard Deviation 1.362	1.615 units on a scale Standard Deviation 1.801

SECONDARY outcome

Timeframe: 6 weeks postoperatively

Population: Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.

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.

Outcome measures

Measure	Evicel n=95 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Visual Analog Pain Scale (During Activity) at 6 Weeks	2.821 units on a scale Standard Deviation 1.972	3.25 units on a scale Standard Deviation 2.167

SECONDARY outcome

Timeframe: 6 weeks postoperatively

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.

Outcome measures

Measure	Evicel n=95 Participants 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.	No Evicel n=100 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Visual Analog Pain Scale (During Therapy) at 6 Weeks	4.479 units on a scale Standard Deviation 2.389	4.62 units on a scale Standard Deviation 2.597

SECONDARY outcome

Timeframe: 6 weeks postoperatively

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.

Outcome measures

Measure	Evicel n=95 Participants 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.	No Evicel n=99 Participants Patients will receive standard treatment for bleeding as practiced at HSS.
Visual Analog Pain Scale (At Night) At 6 Weeks	2.898 units on a scale Standard Deviation 2.192	2.813 units on a scale Standard Deviation 2.340

Adverse Events

Evicel

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

no Evicel

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Evicel n=98 participants at risk 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.	no Evicel n=102 participants at risk Patients will receive standard treatment for bleeding as practiced at HSS.
Skin and subcutaneous tissue disorders Wound Healing Problem	2.0% 2/98 • Number of events 2	0.00% 0/102
Gastrointestinal disorders GI Related Problems	5.1% 5/98 • Number of events 5	3.9% 4/102 • Number of events 4
Cardiac disorders Cardiac or Blood Pressure Issues	12.2% 12/98 • Number of events 12	7.8% 8/102 • Number of events 8
Renal and urinary disorders Urinary Tract Infections	1.0% 1/98 • Number of events 1	0.98% 1/102 • Number of events 1
General disorders Fever	4.1% 4/98 • Number of events 4	2.9% 3/102 • Number of events 3
General disorders Confusion	4.1% 4/98 • Number of events 4	0.98% 1/102 • Number of events 1

Additional Information

Dr. Mark P. Figgie

Hospital for Special Surgery

Phone: 212-606-1932

Email: figgiem@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place