Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ethicon, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
No additional data desired
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| no evicel | No Intervention | Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evicel fibrin sealant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin on Day 0 Compared to Preoperatively | preoperatively and on the day of surgery | |
| Change in Hematocrit on Day 0 Compared to Preoperatively | preoperatively and day of surgery | |
| Change in Hemoglobin On Day 1 Compared to Preoperatively | preoperatively and one day after surgery | |
| Change in Hematocrit on Day 1 Compared to Preoperatively | preoperatively and one day after surgery | |
| Change in Hemoglobin on Day 2 Compared to Preoperatively | preoperatively and two days after surgery | |
| Change in Hematocrit on Day 2 Compared to Preoperatively | preoperatively and two days after surgery | |
| Drain Output | A measurement of the amount of blood drained from the knee. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | preoperatively and two days after surgery |
Not provided
Inclusion Criteria:
- Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark P Figgie, M.D | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Not provided
| Label | URL |
|---|---|
| Ethicon website | View source |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No Evicel | Patients will receive standard treatment for bleeding as practiced at HSS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin on Day 0 Compared to Preoperatively | 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. | Posted | Mean | Standard Deviation | g/dL | preoperatively and on the day of surgery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Healing Problem | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark P. Figgie | Hospital for Special Surgery | 212-606-1932 | figgiem@hss.edu |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| three days postoperatively |
| Range of Motion on Day 3 |
A measurement of the degrees of motion of the operated knee three days after surgery. |
| 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. | 3 days postoperatively |
| Range of Motion at 6 Weeks | A measurement of the degrees of motion of the operated knee six weeks after surgery. | 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. | 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. | 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. | 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. | 6 weeks postoperatively |
| BG001 | no Evicel | Patients will receive standard treatment for bleeding as practiced at HSS. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients will receive standard treatment for bleeding as practiced at HSS. |
|
|
| Secondary | 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. | All patients who completed the study were included in analysis. | Posted | Mean | Standard Deviation | ratio | preoperatively and two days after surgery |
|
|
|
| Secondary | Range of Motion on Day 3 | A measurement of the degrees of motion of the operated knee three days after surgery. | Posted | Mean | Standard Error | degrees | 3 days postoperatively |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | points on VAS scale | 3 days postoperatively |
|
|
|
| Primary | Change in Hematocrit on Day 0 Compared to Preoperatively | 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. | Posted | Mean | Standard Error | percentage of red blood cell | preoperatively and day of surgery |
|
|
|
| Primary | Change in Hemoglobin On Day 1 Compared to Preoperatively | 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. | Posted | Mean | Standard Deviation | g/dL | preoperatively and one day after surgery |
|
|
|
| Primary | Change in Hematocrit on Day 1 Compared to Preoperatively | 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. | Posted | Mean | Standard Deviation | percentage of red blood cell | preoperatively and one day after surgery |
|
|
|
| Primary | Change in Hemoglobin on Day 2 Compared to Preoperatively | 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. | Posted | Mean | Standard Deviation | g/dL | preoperatively and two days after surgery |
|
|
|
| Primary | Change in Hematocrit on Day 2 Compared to Preoperatively | 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. | Posted | Mean | Standard Deviation | percentage of red blood cell | preoperatively and two days after surgery |
|
|
|
| Primary | Drain Output | A measurement of the amount of blood drained from the knee. | 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 | Posted | Mean | Standard Error | mL | 24 hours post-operatively |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | units | perioperatively |
|
|
|
| Primary | 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. | All patients who completed the study were included in analysis. | Posted | Median | Standard Deviation | units | three days postoperatively |
|
|
|
| Secondary | Range of Motion at 6 Weeks | A measurement of the degrees of motion of the operated knee six weeks after surgery. | Patients whose range of motion at 6-week followup appointment was taken were included in analysis. | Posted | Mean | Standard Deviation | degrees | 6 weeks postoperatively |
|
|
|
| Secondary | 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. | Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks postoperatively |
|
|
|
| Secondary | 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. | Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks postoperatively |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks postoperatively |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks postoperatively |
|
|
|
| 0 |
| 98 |
| 28 |
| 98 |
| EG001 | no Evicel | Patients will receive standard treatment for bleeding as practiced at HSS. | 0 | 102 | 17 | 102 |
| GI Related Problems | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cardiac or Blood Pressure Issues | Cardiac disorders | Non-systematic Assessment |
|
| Urinary Tract Infections | Renal and urinary disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Confusion | General disorders | Non-systematic Assessment |
|
Not provided
Not provided