Trial Outcomes & Findings for Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System (NCT NCT02359994)

Last Updated: 2022-03-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

324 participants

Primary outcome timeframe

7 minutes following application

Results posted on

2022-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	PerClot Participants received up to two 5 gram bellows during study procedure.	Arista Active Control. Participants received up to two 5 gram bellows during study procedure.
Overall Population Study STARTED	161	163
Overall Population Study Treated	160	162
Overall Population Study COMPLETED	156	155
Overall Population Study NOT COMPLETED	5	8
Extended Oncology 24-Month Survival STARTED	85	93
Extended Oncology 24-Month Survival COMPLETED	65	72
Extended Oncology 24-Month Survival NOT COMPLETED	20	21

Reasons for withdrawal

Reasons for withdrawal
Measure	PerClot Participants received up to two 5 gram bellows during study procedure.	Arista Active Control. Participants received up to two 5 gram bellows during study procedure.
Overall Population Study Adverse Event	1	1
Overall Population Study Death	1	5
Overall Population Study Lost to Follow-up	1	1
Overall Population Study Withdrawal by Subject	1	0
Overall Population Study Canceled appointment and followed up with their primary care physician instead.	1	0
Overall Population Study Remained in the long term care facility to which the subject was discharged.	0	1
Extended Oncology 24-Month Survival Death	19	21
Extended Oncology 24-Month Survival Lost to Follow-up	1	0

Baseline Characteristics

Age is unknown for one PerClot subject.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PerClot n=161 Participants Participants received up to two 5 gram bellows during index procedure.	Arista n=163 Participants Active Control. Participants received up to two 5 gram bellows during index procedure.	Total n=324 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 13.76 • n=160 Participants • Age is unknown for one PerClot subject.	59.2 years STANDARD_DEVIATION 13.85 • n=163 Participants • Age is unknown for one PerClot subject.	59.2 years STANDARD_DEVIATION 13.78 • n=323 Participants • Age is unknown for one PerClot subject.
Sex: Female, Male Female	56 Participants n=161 Participants	65 Participants n=163 Participants	121 Participants n=324 Participants
Sex: Female, Male Male	105 Participants n=161 Participants	98 Participants n=163 Participants	203 Participants n=324 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=161 Participants	9 Participants n=163 Participants	21 Participants n=324 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=161 Participants	154 Participants n=163 Participants	302 Participants n=324 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=161 Participants	0 Participants n=163 Participants	1 Participants n=324 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=161 Participants	0 Participants n=163 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Asian	5 Participants n=161 Participants	2 Participants n=163 Participants	7 Participants n=324 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=161 Participants	0 Participants n=163 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Black or African American	7 Participants n=161 Participants	15 Participants n=163 Participants	22 Participants n=324 Participants
Race (NIH/OMB) White	147 Participants n=161 Participants	141 Participants n=163 Participants	288 Participants n=324 Participants
Race (NIH/OMB) More than one race	2 Participants n=161 Participants	5 Participants n=163 Participants	7 Participants n=324 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=161 Participants	0 Participants n=163 Participants	0 Participants n=324 Participants
Region of Enrollment United States	161 participants n=161 Participants	163 participants n=163 Participants	324 participants n=324 Participants
Bleeding Severity Score 0	0 Participants n=161 Participants	0 Participants n=163 Participants	0 Participants n=324 Participants
Bleeding Severity Score 1	93 Participants n=161 Participants	92 Participants n=163 Participants	185 Participants n=324 Participants
Bleeding Severity Score 2	68 Participants n=161 Participants	71 Participants n=163 Participants	139 Participants n=324 Participants
Bleeding Severity Score 3	0 Participants n=161 Participants	0 Participants n=163 Participants	0 Participants n=324 Participants
Bleeding Severity Score 4	0 Participants n=161 Participants	0 Participants n=163 Participants	0 Participants n=324 Participants
Bleeding Severity Score 5	0 Participants n=161 Participants	0 Participants n=163 Participants	0 Participants n=324 Participants
Systolic Blood Pressure	135.3 mmHg STANDARD_DEVIATION 18.48 • n=160 Participants • Systolic blood pressure is unknown for one PerClot subject.	131.4 mmHg STANDARD_DEVIATION 20.86 • n=163 Participants • Systolic blood pressure is unknown for one PerClot subject.	133.3 mmHg STANDARD_DEVIATION 19.78 • n=323 Participants • Systolic blood pressure is unknown for one PerClot subject.
Diastolic Blood Pressure	77.7 mmHg STANDARD_DEVIATION 11.98 • n=160 Participants • Diastolic blood pressure is unknown for one PerClot subject.	74.9 mmHg STANDARD_DEVIATION 11.75 • n=163 Participants • Diastolic blood pressure is unknown for one PerClot subject.	76.3 mmHg STANDARD_DEVIATION 19.78 • n=323 Participants • Diastolic blood pressure is unknown for one PerClot subject.
Height	173.3 cm STANDARD_DEVIATION 10.09 • n=161 Participants	172.7 cm STANDARD_DEVIATION 9.69 • n=163 Participants	173.0 cm STANDARD_DEVIATION 9.88 • n=324 Participants
Hematocrit	39.8 percent blood volume STANDARD_DEVIATION 4.40 • n=161 Participants	39.7 percent blood volume STANDARD_DEVIATION 5.12 • n=163 Participants	39.7 percent blood volume STANDARD_DEVIATION 4.77 • n=324 Participants
Hemoglobin	13.2 g/dL STANDARD_DEVIATION 1.57 • n=161 Participants	13.1 g/dL STANDARD_DEVIATION 1.83 • n=163 Participants	13.2 g/dL STANDARD_DEVIATION 1.70 • n=324 Participants
Platelet Count	212 platelets*10^3/mcl n=146 Participants • Platelet count is unknown for fifteen (15) PerClot subjects and ten (10) Arista subjects.	227.0 platelets*10^3/mcl n=153 Participants • Platelet count is unknown for fifteen (15) PerClot subjects and ten (10) Arista subjects.	220.0 platelets*10^3/mcl n=299 Participants • Platelet count is unknown for fifteen (15) PerClot subjects and ten (10) Arista subjects.
Temperature	36.6 degrees Celsius STANDARD_DEVIATION 0.42 • n=160 Participants • Temperature is unknown for one (1) PerClot subject and four (4) Arista subjects.	36.6 degrees Celsius STANDARD_DEVIATION 0.38 • n=159 Participants • Temperature is unknown for one (1) PerClot subject and four (4) Arista subjects.	36.6 degrees Celsius STANDARD_DEVIATION 0.40 • n=319 Participants • Temperature is unknown for one (1) PerClot subject and four (4) Arista subjects.
Therapeutic Area Cardiac	43 Participants n=161 Participants	43 Participants n=163 Participants	86 Participants n=324 Participants
Therapeutic Area General	75 Participants n=161 Participants	80 Participants n=163 Participants	155 Participants n=324 Participants
Therapeutic Area Urology	43 Participants n=161 Participants	40 Participants n=163 Participants	83 Participants n=324 Participants
Type I Diabetes	2 Participants n=161 Participants	1 Participants n=163 Participants	3 Participants n=324 Participants
Type II Diabetes	31 Participants n=161 Participants	36 Participants n=163 Participants	67 Participants n=324 Participants
Weight	86.0 kg STANDARD_DEVIATION 19.90 • n=161 Participants	87.0 kg STANDARD_DEVIATION 20.44 • n=163 Participants	86.5 kg STANDARD_DEVIATION 20.15 • n=324 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PerClot n=160 Participants Participants received up to two 5 gram bellows during index procedure.	Arista n=162 Participants Active Control. Participants received up to two 5 gram bellows during index procedure.
Number of Participants With Achievement of Hemostasis at 7 Minutes	145 Participants	149 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PerClot n=160 Participants Participants received up to two 5 gram bellows during index procedure.	Arista n=162 Participants Active Control. Participants received up to two 5 gram bellows during index procedure.
Number of Participants With Achievement of Hemostasis at 5 Minutes	144 Participants	138 Participants

Adverse Events

PerClot

Serious events: 44 serious events

Other events: 89 other events

Deaths: 1 deaths

Arista

Serious events: 44 serious events

Other events: 78 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Priya Patel

Artivion

Phone: 678-290-4358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators will postpone single-site publications until after publication or disclosure of data representative of the entire study (i.e., from all study sites).
Publication restrictions are in place

Restriction type: OTHER

Measure	PerClot n=161 participants at risk Participants received up to two 5 gram bellows during index procedure.	Arista n=163 participants at risk Active Control. Participants received up to two 5 gram bellows during index procedure.
Blood and lymphatic system disorders Anemia	11.8% 19/161 • Number of events 19 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	7.4% 12/163 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Blood and lymphatic system disorders Leukocytosis	5.6% 9/161 • Number of events 9 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	7.4% 12/163 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Cardiac disorders Atrial Fibrillation	6.2% 10/161 • Number of events 10 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	5.5% 9/163 • Number of events 9 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Gastrointestinal disorders Constipation	9.9% 16/161 • Number of events 16 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	7.4% 12/163 • Number of events 13 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Gastrointestinal disorders Abdominal Pain	8.7% 14/161 • Number of events 14 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	8.6% 14/163 • Number of events 14 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Gastrointestinal disorders Nausea	8.1% 13/161 • Number of events 13 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	8.6% 14/163 • Number of events 14 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
General disorders Fever	7.5% 12/161 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	3.1% 5/163 • Number of events 5 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Metabolism and nutrition disorders Hypophosphatemia	13.7% 22/161 • Number of events 22 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	14.1% 23/163 • Number of events 24 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Metabolism and nutrition disorders Hyperglycemia	8.7% 14/161 • Number of events 14 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	7.4% 12/163 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Metabolism and nutrition disorders Hypokalemia	6.8% 11/161 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	7.4% 12/163 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Renal and urinary disorders Acute Kidney Injury	6.8% 11/161 • Number of events 11 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	6.1% 10/163 • Number of events 10 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	12.4% 20/161 • Number of events 20 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	11.0% 18/163 • Number of events 18 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Respiratory, thoracic and mediastinal disorders Atelectasis	8.7% 14/161 • Number of events 15 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	6.1% 10/163 • Number of events 10 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.5% 12/161 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	5.5% 9/163 • Number of events 9 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Vascular disorders Hypotension	7.5% 12/161 • Number of events 12 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.	11.7% 19/163 • Number of events 20 • Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.