Blood Loss
Conditions
Keywords
To decrease blood loss during knee surgery
Brief summary
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.
Detailed description
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment. Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given. As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.
Interventions
FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Sponsors
Baxter Healthcare Corporation
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Single Knee replacement for arthritis of the knee
Exclusion criteria
* No inflammatory arthritis (ie. Rheumatoid arthritis) * No allergies to cow meat (bovine allergies * No history of bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Homologous Amount of Transfusion | three days postoperatively |
| 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 | 24 hours postoperatively |
| Autologous Amount of Transfusion | three days postoperatively |
| Change in Hemoglobin on Day 0 Compared to Preoperatively | preoperatively and on the 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 1 day after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion on Day 3 | 3days postoperatively | — |
| Visual Analog Pain Scale on Day 3 | 3 days postoperatively | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. |
| Range of Motion at Six Weeks | 6 weeks postoperatively | — |
| Visual Analog Pain Scale at 6 Weeks | 6 weeks postoperatively | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. |
Countries
United States
Participant flow
Recruitment details
Inclusion Criteria: 1)Diagnosis of knee arthritis in patients medically suitable to undergo unilateral TKA. Pre-operative Exclusion Criteria: 1. Known allergies to products of bovine origin. 2. History of bleeding disorders. 3. Pre- or peri-operative complication.
Participants by arm
| Arm | Count |
|---|---|
| Hemostatic Matrix 2 vials of Floseal applied once at the end of surgery | 97 |
| Control No intervention. | 99 |
| Total | 196 |
Baseline characteristics
| Characteristic | Control | Hemostatic Matrix | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 77 Participants | 103 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 20 Participants | 93 Participants |
| Age, Continuous | 70.40 years STANDARD_DEVIATION 10.47 | 72.78 years STANDARD_DEVIATION 8.9 | 71.58 years STANDARD_DEVIATION 9.77 |
| Region of Enrollment United States | 99 participants | 97 participants | 196 participants |
| Sex: Female, Male Female | 71 Participants | 65 Participants | 136 Participants |
| Sex: Female, Male Male | 28 Participants | 32 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 97 | 6 / 99 |
| serious Total, serious adverse events | 0 / 97 | 0 / 99 |
Outcome results
Primary
Autologous Amount of Transfusion
Time frame: three days postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Autologous Amount of Transfusion | .828 units of blood | Standard Deviation 0.746 |
| Control | Autologous Amount of Transfusion | .854 units of blood | Standard Deviation 0.754 |
Primary
Change in Hematocrit on Day 1 Compared to Preoperatively
Time frame: preoperatively and 1 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Change in Hematocrit on Day 1 Compared to Preoperatively | -5.075 g/L | Standard Deviation 3.298 |
| Control | Change in Hematocrit on Day 1 Compared to Preoperatively | -5.749 g/L | Standard Deviation 3.652 |
Primary
Change in Hematocrit on Day 2 Compared to Preoperatively
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Change in Hematocrit on Day 2 Compared to Preoperatively | -7.013 g/L | Standard Deviation 4.183 |
| Control | Change in Hematocrit on Day 2 Compared to Preoperatively | -7.418 g/L | Standard Deviation 3.904 |
Primary
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Change in Hemoglobin on Day 0 Compared to Preoperatively | -4.484 g/L | Standard Deviation 2.637 |
| Control | Change in Hemoglobin on Day 0 Compared to Preoperatively | -4.305 g/L | Standard Deviation 2.682 |
Primary
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Change in Hemoglobin on Day 0 Compared to Preoperatively | -1.277 g/dL | Standard Deviation 0.88 |
| Control | Change in Hemoglobin on Day 0 Compared to Preoperatively | -1.241 g/dL | Standard Deviation 0.883 |
Primary
Change in Hemoglobin On Day 1 Compared to Preoperatively
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Change in Hemoglobin On Day 1 Compared to Preoperatively | -1.528 g/dL | Standard Deviation 1.132 |
| Control | Change in Hemoglobin On Day 1 Compared to Preoperatively | -1.816 g/dL | Standard Deviation 1.168 |
Primary
Change in Hemoglobin on Day 2 Compared to Preoperatively
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Change in Hemoglobin on Day 2 Compared to Preoperatively | -2.265 g/dL | Standard Deviation 1.443 |
| Control | Change in Hemoglobin on Day 2 Compared to Preoperatively | -2.359 g/dL | Standard Deviation 1.246 |
Primary
Drain Output
Time frame: 24 hours postoperatively
Population: Drain output at 24 hours was recorded for all patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Drain Output | 711 mL | Standard Deviation 287 |
| Control | Drain Output | 702 mL | Standard Deviation 314.7 |
Primary
Homologous Amount of Transfusion
Time frame: three days postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Homologous Amount of Transfusion | .247 units of blood | Standard Deviation 0.525 |
| Control | Homologous Amount of Transfusion | .337 units of blood | Standard Deviation 0.738 |
Secondary
Range of Motion at Six Weeks
Time frame: 6 weeks postoperatively
Population: Patients whose range of motion at 6-week followup appointment was taken were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Range of Motion at Six Weeks | 111.41 degrees | Standard Deviation 14.25 |
| Control | Range of Motion at Six Weeks | 112.97 degrees | Standard Deviation 12.92 |
Secondary
Range of Motion on Day 3
Time frame: 3days postoperatively
Population: Patients whose range of motion at 3 day followup appointment was taken were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Range of Motion on Day 3 | 67.88 degrees | Standard Deviation 14.54 |
| Control | Range of Motion on Day 3 | 68.96 degrees | Standard Deviation 16.01 |
Secondary
Visual Analog Pain Scale at 6 Weeks
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
Time frame: 6 weeks postoperatively
Population: Patients whose pain level at 6-week followup appointment was taken were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Visual Analog Pain Scale at 6 Weeks | 2.753 points on visual analog pain scale | Standard Deviation 2.09 |
| Control | Visual Analog Pain Scale at 6 Weeks | 2.91 points on visual analog pain scale | Standard Deviation 2.17 |
Secondary
Visual Analog Pain Scale on Day 3
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
Time frame: 3 days postoperatively
Population: All patients whose pain score was collected were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemostatic Matrix | Visual Analog Pain Scale on Day 3 | 2.99 points on visual analog pain scale | Standard Deviation 2.311 |
| Control | Visual Analog Pain Scale on Day 3 | 2.78 points on visual analog pain scale | Standard Deviation 2.44 |