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

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT01235715
• Collaborator: Ethicon, Inc. (Industry)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Evicel fibrin sealant	Phase 4

Detailed Description

No additional data desired

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Evicel fibrin sealant; 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.
No Intervention: no evicel Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.

Outcome Measures

Primary Outcome Measures

1. Change in Hemoglobin on Day 0 Compared to Preoperatively [preoperatively and on the day of surgery]

2. Change in Hematocrit on Day 0 Compared to Preoperatively [preoperatively and day of surgery]

3. Change in Hemoglobin On Day 1 Compared to Preoperatively [preoperatively and one day after surgery]

4. Change in Hematocrit on Day 1 Compared to Preoperatively [preoperatively and one day after surgery]

5. Change in Hemoglobin on Day 2 Compared to Preoperatively [preoperatively and two days after surgery]

6. Change in Hematocrit on Day 2 Compared to Preoperatively [preoperatively and two days after surgery]

7. Drain Output [24 hours post-operatively]

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

8. Number of Autologous Transfusion Units Over the Course of the Hospital Stay [perioperatively]

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

9. Units of Homologous Transfusion Over the Course of the Hospital Stay [three days postoperatively]

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

Secondary Outcome Measures

1. Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively [preoperatively and two days after surgery]

   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.

2. Range of Motion on Day 3 [3 days postoperatively]

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

3. Visual Analog Pain Scale on Day 3 [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.

4. Range of Motion at 6 Weeks [6 weeks postoperatively]

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

5. Visual Analog Pain Scale (at Rest) at 6 Weeks [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 rest, the patient indicates their level of pain while seated or lying down, not moving.

6. Visual Analog Pain Scale (During Activity) at 6 Weeks [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 while doing activities of daily living such as walking and moving from sitting to standing.

7. Visual Analog Pain Scale (During Therapy) at 6 Weeks [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.

8. Visual Analog Pain Scale (At Night) At 6 Weeks [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York
• Ethicon, Inc.

Investigators

• Principal Investigator: Mark P Figgie, M.D, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Ethicon website

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT01235715
• Other Study ID Numbers: 29054
• First Posted: Nov 5, 2010
• Last Update Posted: Oct 29, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Hospital for Special Surgery, New York: osteoarthritis; total knee replacement
• Additional relevant MeSH terms: Osteoarthritis; Fibrin Tissue Adhesive

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Period Title: Overall Study
STARTED	98	102
COMPLETED	98	100
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Evicel	no Evicel	Total
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.	Total of all reporting groups
Overall Participants	98	102	200
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 34.7%	41 40.2%	75 37.5%
>=65 years	64 65.3%	61 59.8%	125 62.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.12 (9.88)	66.38 (8.47)	67 (10)
Sex: Female, Male (Count of Participants)
Female	57 58.2%	59 57.8%	116 58%
Male	41 41.8%	43 42.2%	84 42%
Region of Enrollment (participants) [Number]
United States	98 100%	102 100%	200 100%

Outcome Measures

1. Primary Outcome

Title	Change in Hemoglobin on Day 0 Compared to Preoperatively
Time Frame	preoperatively and on the day of surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	95	96
Mean (Standard Deviation) [g/dL]	-1.548 (.745)	-1.458 (.815)

2. Secondary Outcome

Title	Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively
Description	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.
Time Frame	preoperatively and two days after surgery

Outcome Measure Data

Analysis Population Description

All patients who completed the study were included in analysis.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	98	100
Mean (Standard Deviation) [ratio]	.363 (.421)	0.309 (0.514)

3. Secondary Outcome

Title	Range of Motion on Day 3
Description	A measurement of the degrees of motion of the operated knee three days after surgery.
Time Frame	3 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	98	100
Mean (Standard Error) [degrees]	112.4 (1.983)	114.1 (1.983)

4. Secondary Outcome

Title	Visual Analog Pain Scale on Day 3
Description	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.
Time Frame	3 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	98	100
Mean (Standard Error) [points on VAS scale]	4.3 (1.983)	3.9 (1.983)

5. Primary Outcome

Title	Change in Hematocrit on Day 0 Compared to Preoperatively
Time Frame	preoperatively and day of surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	94	96
Mean (Standard Error) [percentage of red blood cell]	-4.639 (2.275)	-4.220 (2.537)

6. Primary Outcome

Title	Change in Hemoglobin On Day 1 Compared to Preoperatively
Time Frame	preoperatively and one day after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	95	99
Mean (Standard Deviation) [g/dL]	-2.607 (0.986)	-2.480 (1.063)

7. Primary Outcome

Title	Change in Hematocrit on Day 1 Compared to Preoperatively
Time Frame	preoperatively and one day after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	94	99
Mean (Standard Deviation) [percentage of red blood cell]	-7.382 (2.801)	-7.199 (3.381)

8. Primary Outcome

Title	Change in Hemoglobin on Day 2 Compared to Preoperatively
Time Frame	preoperatively and two days after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	94	98
Mean (Standard Deviation) [g/dL]	-3.419 (1.437)	-3.497 (1.157)

9. Primary Outcome

Title	Change in Hematocrit on Day 2 Compared to Preoperatively
Time Frame	preoperatively and two days after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	93	98
Mean (Standard Deviation) [percentage of red blood cell]	-9.676 (4.540)	-10.100 (3.597)

10. Primary Outcome

Title	Drain Output
Description	A measurement of the amount of blood drained from the knee.
Time Frame	24 hours post-operatively

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	98	100
Mean (Standard Error) [mL]	780 (54.23)	673 (54.23)

11. Primary Outcome

Title	Number of Autologous Transfusion Units Over the Course of the Hospital Stay
Description	Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time Frame	perioperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	98	100
Mean (Standard Error) [units]	0.38 (0.041)	0.46 (0.041)

12. Primary Outcome

Title	Units of Homologous Transfusion Over the Course of the Hospital Stay
Description	Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time Frame	three days postoperatively

Outcome Measure Data

Analysis Population Description

All patients who completed the study were included in analysis.

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	98	100
Median (Standard Deviation) [units]	0.276 (0.729)	0.228 (0.581)

13. Secondary Outcome

Title	Range of Motion at 6 Weeks
Description	A measurement of the degrees of motion of the operated knee six weeks after surgery.
Time Frame	6 weeks postoperatively

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	96	98
Mean (Standard Deviation) [degrees]	114 (10.8)	115 (12.4)

14. Secondary Outcome

Title	Visual Analog Pain Scale (at Rest) at 6 Weeks
Description	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.
Time Frame	6 weeks postoperatively

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	95	100
Mean (Standard Deviation) [units on a scale]	1.326 (1.362)	1.615 (1.801)

15. Secondary Outcome

Title	Visual Analog Pain Scale (During Activity) at 6 Weeks
Description	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.
Time Frame	6 weeks postoperatively

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	95	100
Mean (Standard Deviation) [units on a scale]	2.821 (1.972)	3.25 (2.167)

16. Secondary Outcome

Title	Visual Analog Pain Scale (During Therapy) at 6 Weeks
Description	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.
Time Frame	6 weeks postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evicel	no Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	95	100
Mean (Standard Deviation) [units on a scale]	4.479 (2.389)	4.62 (2.597)

17. Secondary Outcome

Title	Visual Analog Pain Scale (At Night) At 6 Weeks
Description	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.
Time Frame	6 weeks postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Evicel	No Evicel
Arm/Group Description	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.	Patients will receive standard treatment for bleeding as practiced at HSS.
Measure Participants	95	99
Mean (Standard Deviation) [units on a scale]	2.898 (2.192)	2.813 (2.340)

Adverse Events

Arm/Group Title	Evicel		no Evicel
Arm/Group Description	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.		Patients will receive standard treatment for bleeding as practiced at HSS.
All Cause Mortality
	Evicel		no Evicel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Evicel		no Evicel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/102 (0%)
Other (Not Including Serious) Adverse Events
	Evicel		no Evicel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/98 (28.6%)		17/102 (16.7%)
Cardiac disorders
Cardiac or Blood Pressure Issues	12/98 (12.2%)	12	8/102 (7.8%)	8
Gastrointestinal disorders
GI Related Problems	5/98 (5.1%)	5	4/102 (3.9%)	4
General disorders
Fever	4/98 (4.1%)	4	3/102 (2.9%)	3
Confusion	4/98 (4.1%)	4	1/102 (1%)	1
Renal and urinary disorders
Urinary Tract Infections	1/98 (1%)	1	1/102 (1%)	1
Skin and subcutaneous tissue disorders
Wound Healing Problem	2/98 (2%)	2	0/102 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.