Blood Loss, Surgical
Conditions
Keywords
hemostasis
Brief summary
This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device. Three hundred and twenty four subjects across a maximum of 25 investigational sites undergoing open elective cardiac, general, or urological surgical procedures who meet the eligibility criteria will be intraoperatively randomized to receive no more than the entire contents of up to two 5 gram bellows of either the investigational device or a control hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm² and whose anatomic application site is smaller than or equal to 47cm², when bleeding is within the pre-defined bleeding severity range after any applicable conventional means for hemostasis are attempted as specified in the intraoperative procedures. Each investigational site is expected to enroll approximately 13-40 subjects. All investigational sites will be located in the U.S. Follow-up will occur at hospital discharge and 6 weeks post-device application. For oncologic subjects, an additional follow up will occur at 24 months post device application.
Interventions
DEVICEPerClot Polysaccharide Hemostatic System
During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of PerClot. The prescribed hemostatic agent will be applied according to its Instructions for Use.
DEVICEArista AH
During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of the control device. The prescribed hemostatic agent will be applied according to its Instructions for Use.
Sponsors
Artivion Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Preoperative inclusion: * Subject is undergoing one of the following open elective cardiac, general, or urological surgical procedures: Cardiac procedure (Epicardium); Cardiac procedure (aortic anastomosis or aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy. * Subject is willing and able to give prior written informed consent for investigation participation; and * Subject is \> 22 years of age. * Intraoperative inclusion: * Subject is undergoing one of the following elective procedures: Cardiac procedure (Epicardium); Cardiac procedure (Aortic Anastomosis or Aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy. * Subject in whom all visible vessels or suture holes greater than or equal to 2mm in diameter have been ligated; * Subject in whom there is bleeding at the specified area for each surgical procedure after any applicable conventional means for hemostasis are attempted as specified by the intraoperative protocol; * Subject in whom the anatomic site is equal to or less than 25cm²; * Subject in whom the anatomic application site is equal to or less than 47cm²; and * Subject in whom the bleeding flux from the identified lesion is \> 0.000040\[g/(cm²•s)\] and ≤0.013\[g/(cm²•s)\].
Exclusion criteria
* Preoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Achievement of Hemostasis at 7 Minutes | 7 minutes following application | The primary objective of this clinical investigation is to demonstrate non-inferiority in the achievement of hemostasis of the treated bleeding site at 7 minutes in participants receiving PerClot compared to those receiving a control hemostatic device. The primary endpoint is the percentage of participants achieving hemostasis of the treated lesion at 7 minutes in each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Achievement of Hemostasis at 5 Minutes | 5 minutes following application | The secondary objective of this investigation is to compare the achievement of hemostasis of the treated bleeding site at 5 minutes for participants receiving PerClot compared to those receiving a control hemostatic device. The secondary endpoint is the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in each treatment group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PerClot Participants received up to two 5 gram bellows during index procedure. | 161 |
| Arista Active Control. Participants received up to two 5 gram bellows during index procedure. | 163 |
| Total | 324 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Extended Oncology 24-Month Survival | Death | 19 | 21 |
| Extended Oncology 24-Month Survival | Lost to Follow-up | 1 | 0 |
| Overall Population Study | Adverse Event | 1 | 1 |
| Overall Population Study | Canceled appointment and followed up with their primary care physician instead. | 1 | 0 |
| Overall Population Study | Death | 1 | 5 |
| Overall Population Study | Lost to Follow-up | 1 | 1 |
| Overall Population Study | Remained in the long term care facility to which the subject was discharged. | 0 | 1 |
| Overall Population Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | PerClot | Arista |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 13.78 | 59.1 years STANDARD_DEVIATION 13.76 | 59.2 years STANDARD_DEVIATION 13.85 |
| Bleeding Severity Score 0 | 0 Participants | 0 Participants | 0 Participants |
| Bleeding Severity Score 1 | 185 Participants | 93 Participants | 92 Participants |
| Bleeding Severity Score 2 | 139 Participants | 68 Participants | 71 Participants |
| Bleeding Severity Score 3 | 0 Participants | 0 Participants | 0 Participants |
| Bleeding Severity Score 4 | 0 Participants | 0 Participants | 0 Participants |
| Bleeding Severity Score 5 | 0 Participants | 0 Participants | 0 Participants |
| Diastolic Blood Pressure | 76.3 mmHg STANDARD_DEVIATION 19.78 | 77.7 mmHg STANDARD_DEVIATION 11.98 | 74.9 mmHg STANDARD_DEVIATION 11.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 12 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 302 Participants | 148 Participants | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Height | 173.0 cm STANDARD_DEVIATION 9.88 | 173.3 cm STANDARD_DEVIATION 10.09 | 172.7 cm STANDARD_DEVIATION 9.69 |
| Hematocrit | 39.7 percent blood volume STANDARD_DEVIATION 4.77 | 39.8 percent blood volume STANDARD_DEVIATION 4.4 | 39.7 percent blood volume STANDARD_DEVIATION 5.12 |
| Hemoglobin | 13.2 g/dL STANDARD_DEVIATION 1.7 | 13.2 g/dL STANDARD_DEVIATION 1.57 | 13.1 g/dL STANDARD_DEVIATION 1.83 |
| Platelet Count | 220.0 platelets*10^3/mcl | 212 platelets*10^3/mcl | 227.0 platelets*10^3/mcl |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 288 Participants | 147 Participants | 141 Participants |
| Region of Enrollment United States | 324 participants | 161 participants | 163 participants |
| Sex: Female, Male Female | 121 Participants | 56 Participants | 65 Participants |
| Sex: Female, Male Male | 203 Participants | 105 Participants | 98 Participants |
| Systolic Blood Pressure | 133.3 mmHg STANDARD_DEVIATION 19.78 | 135.3 mmHg STANDARD_DEVIATION 18.48 | 131.4 mmHg STANDARD_DEVIATION 20.86 |
| Temperature | 36.6 degrees Celsius STANDARD_DEVIATION 0.4 | 36.6 degrees Celsius STANDARD_DEVIATION 0.42 | 36.6 degrees Celsius STANDARD_DEVIATION 0.38 |
| Therapeutic Area Cardiac | 86 Participants | 43 Participants | 43 Participants |
| Therapeutic Area General | 155 Participants | 75 Participants | 80 Participants |
| Therapeutic Area Urology | 83 Participants | 43 Participants | 40 Participants |
| Type I Diabetes | 3 Participants | 2 Participants | 1 Participants |
| Type II Diabetes | 67 Participants | 31 Participants | 36 Participants |
| Weight | 86.5 kg STANDARD_DEVIATION 20.15 | 86.0 kg STANDARD_DEVIATION 19.9 | 87.0 kg STANDARD_DEVIATION 20.44 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 161 | 5 / 163 |
| other Total, other adverse events | 89 / 161 | 78 / 163 |
| serious Total, serious adverse events | 44 / 161 | 44 / 163 |
Outcome results
Primary
Number of Participants With Achievement of Hemostasis at 7 Minutes
The primary objective of this clinical investigation is to demonstrate non-inferiority in the achievement of hemostasis of the treated bleeding site at 7 minutes in participants receiving PerClot compared to those receiving a control hemostatic device. The primary endpoint is the percentage of participants achieving hemostasis of the treated lesion at 7 minutes in each treatment group.
Time frame: 7 minutes following application
Population: As Treated Population, which consists of all subjects who were randomized and treated with either PerClot or Arista, with subjects analyzed according to the treatment group for the treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PerClot | Number of Participants With Achievement of Hemostasis at 7 Minutes | 145 Participants |
| Arista | Number of Participants With Achievement of Hemostasis at 7 Minutes | 149 Participants |
Comparison: The primary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 7 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 7 minutes in the Arista group, the active control.p-value: 0.00595% CI: [-7.5, 4.8]Farrington-Manning score test
Secondary
Number of Participants With Achievement of Hemostasis at 5 Minutes
The secondary objective of this investigation is to compare the achievement of hemostasis of the treated bleeding site at 5 minutes for participants receiving PerClot compared to those receiving a control hemostatic device. The secondary endpoint is the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in each treatment group.
Time frame: 5 minutes following application
Population: As Treated Population, which consists of all subjects who were randomized and treated with either PerClot or Arista, with subjects analyzed according to the treatment group for the treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PerClot | Number of Participants With Achievement of Hemostasis at 5 Minutes | 144 Participants |
| Arista | Number of Participants With Achievement of Hemostasis at 5 Minutes | 138 Participants |
Comparison: The secondary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 5 minutes in the Arista group, the active control.p-value: <0.00195% CI: [-2.4, 12]Farrington-Manning score test