Transmission, Blood, Recipient/Donor
Conditions
Brief summary
This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.
Detailed description
The OrthoPAT Advance system is being developed by Haemonetics to change the user interface, especially for adding calculations for Estimating Blood Loss- (EBL). The OrthoPAT® serves as the predicate device. The following items will be changed in the OrthoPAT Advance system compared to OrthoPAT: * Software & User Interface - ability to enter irrigant and anti-coagulant volumes and allow Estimated Blood Loss (EBL) calculation to be made by OrthoPAT Advance. * Hardware - * Redesign of reservoir and filter to process blood earlier by reducing hold-up volume and improve fluid visualization in reservoir. * Extended battery life. It is not intended to validate the major changes in the OrthoPAT Advance device (reservoir / filter and EBL), which will be conducted as lab based tests. The correct functioning of the reservoir / filter and EBL changes will be confirmed in the clinical setting in this study. However the most rigorous challenge to the filter will be by presenting the worst case media and this can only be controlled in the laboratory.
Interventions
DEVICEOrthoPat Advance
The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.
Sponsors
Haemonetics Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female over the age of 18 years * Subject is scheduled for a total knee/hip replacement/ revision or a hysterectomy. * Subjects determined eligible per site standard of care for use of intra- and post-operative use of cell salvage device
Exclusion criteria
For subjects where product is transfused * Subject is undergoing a trauma procedure where there is a possibility of contamination from an open wound. * Patient is diagnosed with sepsis. * Patient is diagnosed with sickle-cell anemia. * Malignant cells may be mixed with blood salvaged from the surgical field. * Prostatic or amniotic fluid is mixed with blood salvaged from the surgical field. * Blood salvaged from the surgical field may be contaminated from an active infection at wound/drain site. * Blood salvaged from the surgical field contains topical hemostatic agents, anti-bacterial agents, or wound irrigants not intended for parenteral use. For all subjects: * Subject is undergoing a procedure which involves high, rapid blood loss such as liver transplants, certain cardiovascular procedures, and trauma procedures where blood loss is high (per Investigators judgment). * Any procedure terminated prior to completion by subject request, operator decision or error, or device error. * Any subject with which at least 200mL of filtered blood or 1 full disc is not available for processing and data collection within the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Washed RBC Hematocrit | < 4 hours | The Hematocrit of the RBC shall be \> 50%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Device The 510k cleared OrthoPAT Advance will be used in this standard of care arm. | 76 |
| Control Group The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention. | 8 |
| Total | 84 |
Baseline characteristics
| Characteristic | Investigational Device | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 0 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 8 Participants | 66 Participants |
| Age Continuous | 56 years STANDARD_DEVIATION 19 | 46 years STANDARD_DEVIATION 9 | 55 years STANDARD_DEVIATION 19 |
| Region of Enrollment United States | 76 participants | 8 participants | 84 participants |
| Sex: Female, Male Female | 52 Participants | 8 Participants | 60 Participants |
| Sex: Female, Male Male | 24 Participants | 0 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 73 | 0 / 8 |
| serious Total, serious adverse events | 0 / 73 | 0 / 8 |
Outcome results
Primary
Washed RBC Hematocrit
The Hematocrit of the RBC shall be \> 50%.
Time frame: < 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device | Washed RBC Hematocrit | 55.43 percentage of HcT | Standard Deviation 7.47 |
| Control Group | Washed RBC Hematocrit | 56.48 percentage of HcT | Standard Deviation 5.28 |