Intraoperative Bleeding, Osteoarthritis
Conditions
Keywords
Blood Loss, Hemoglobin, Hematocrit, Blood Transfusions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEvicel Fibrin Spray
10cc syringe dose, once at the end of TKA
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients must be male or female of any race * Ages 18-80 years old * Patients must be undergoing an elective, primary knee arthroplasty performed by the principal investigator
Exclusion criteria
* Allergy or intolerance to the study materials * Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology * History of previous surgeries on the affected joint including previous arthroscopy (open surgeries) * Women that are pregnant or may become pregnant * Patient declines to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary--Percent Change of Pre- to Post-Operative Hemoglobin | Pre-operative to 1 month | 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. |
| Total Blood Loss | Collected during surgery and in first 2-3 days after surgery | Combination of intraoperative and postoperative blood loss for participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Transfusions | 3 days | The number of transfusions each patient receives during their postoperative hospitalization. |
| Postoperative Blood Loss | 3 days | Measured as drainage output from postoperative drains during hospitalization. |
Countries
United States
Participant flow
Pre-assignment details
Prior to randomization, 21 patients were disqualified for protocol violation.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control group. Will not receive the fibrin spray. | 25 |
| 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 | 22 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 3 |
Baseline characteristics
| Characteristic | Treatment Group--Evicel Fibrin Spray | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 18 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 7 Participants | 19 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 9 | 66 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 22 participants | 25 participants | 47 participants |
| Sex: Female, Male Female | 17 Participants | 21 Participants | 38 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
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.
Time frame: Pre-operative to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Primary--Percent Change of Pre- to Post-Operative Hemoglobin | 20.1 Percent Change | Standard Deviation 7 |
| Treatment Group--Evicel Fibrin Spray | Primary--Percent Change of Pre- to Post-Operative Hemoglobin | 22.5 Percent Change | Standard Deviation 5.7 |
p-value: 0.2t-test, 2 sided
Primary
Total Blood Loss
Combination of intraoperative and postoperative blood loss for participants.
Time frame: Collected during surgery and in first 2-3 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Total Blood Loss | 605 mL | Standard Deviation 288 |
| Treatment Group--Evicel Fibrin Spray | Total Blood Loss | 621 mL | Standard Deviation 334 |
p-value: 0.9t-test, 2 sided
Secondary
Postoperative Blood Loss
Measured as drainage output from postoperative drains during hospitalization.
Time frame: 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Postoperative Blood Loss | 543 mL | Standard Deviation 273 |
| Treatment Group--Evicel Fibrin Spray | Postoperative Blood Loss | 555 mL | Standard Deviation 324 |
p-value: 0.9t-test, 2 sided
Secondary
Total Transfusions
The number of transfusions each patient receives during their postoperative hospitalization.
Time frame: 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Total Transfusions | 3 Number of transfusions |
| Treatment Group--Evicel Fibrin Spray | Total Transfusions | 3 Number of transfusions |