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Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.
Study Design
Study design and control methods:
This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray.
Treatment group:
The subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator.
Treatment allocation:
All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.
Trial Population:
The target sample size is 70 patients for both the treatment and control groups (140 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 140 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Control group. Will not receive the fibrin spray. | |
| Treatment Group--Evicel Fibrin Spray | Active Comparator | Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evicel Fibrin Spray | Drug | 10cc syringe dose, once at the end of TKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary--Percent Change of Pre- to Post-Operative Hemoglobin | Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery. | Pre-operative to 1 month |
| Total Blood Loss | Combination of intraoperative and postoperative blood loss for participants. | Collected during surgery and in first 2-3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Transfusions | The number of transfusions each patient receives during their postoperative hospitalization. | 3 days |
| Postoperative Blood Loss | Measured as drainage output from postoperative drains during hospitalization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett R Levine, MD | RUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush Oak Park Hospital | Oak Park | Illinois | 60304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10565650 | Result | Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8. doi: 10.2106/00004623-199911000-00010. | |
| 11679600 | Result |
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Prior to randomization, 21 patients were disqualified for protocol violation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control group. Will not receive the fibrin spray. |
| FG001 | Treatment Group--Evicel Fibrin Spray | Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control group. Will not receive the fibrin spray. |
| BG001 | Treatment Group--Evicel Fibrin Spray | Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA |
| 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 | Primary--Percent Change of Pre- to Post-Operative Hemoglobin | Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery. | Posted | Mean | Standard Deviation | Percent Change | Pre-operative to 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Control group. Will not receive the fibrin spray. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Wound Dehiscence | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Kearns | Rush University | 708-236-2664 | sean_m_kearns@rush.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D016063 | Blood Loss, Surgical |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 3 days |
| Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83(10):1503-5. doi: 10.2106/00004623-200110000-00007. |
| 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 |
|
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|
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| Primary | Total Blood Loss | Combination of intraoperative and postoperative blood loss for participants. | Posted | Mean | Standard Deviation | mL | Collected during surgery and in first 2-3 days after surgery |
|
|
|
|
| Secondary | Total Transfusions | The number of transfusions each patient receives during their postoperative hospitalization. | Posted | Number | Number of transfusions | 3 days |
|
|
|
| Secondary | Postoperative Blood Loss | Measured as drainage output from postoperative drains during hospitalization. | Posted | Mean | Standard Deviation | mL | 3 days |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Treatment Group--Evicel Fibrin Spray | Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA | 0 | 25 | 0 | 25 |
| Deep Vein Thrombosis | Blood and lymphatic system disorders |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |