Trial Outcomes & Findings for Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting (NCT NCT03654560)
NCT ID: NCT03654560
Last Updated: 2020-10-22
Results Overview
The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
236 participants
Primary outcome timeframe
10 minutes
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
HemoStyp
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
118
|
|
Overall Study
COMPLETED
|
114
|
117
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
HemoStyp
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Baseline characteristics by cohort
| Measure |
Surgicel
n=118 Participants
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
Total
n=236 Participants
Total of all reporting groups
|
HemoStyp
n=118 Participants
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
|---|---|---|---|
|
Age, Continuous
|
61.48 years
STANDARD_DEVIATION 16.48 • n=7 Participants
|
60.19 years
STANDARD_DEVIATION 16.32 • n=5 Participants
|
58.89 years
STANDARD_DEVIATION 16.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
Height
|
168.55 cm
STANDARD_DEVIATION 15.5 • n=7 Participants
|
166.69 cm
STANDARD_DEVIATION 19.59 • n=5 Participants
|
164.84 cm
STANDARD_DEVIATION 19.59 • n=5 Participants
|
|
Weight
|
86.48 kg
STANDARD_DEVIATION 49.88 • n=7 Participants
|
83.24 kg
STANDARD_DEVIATION 38.62 • n=5 Participants
|
79.94 kg
STANDARD_DEVIATION 38.62 • n=5 Participants
|
|
Systolic Blood Pressure
|
124.53 mmHg
STANDARD_DEVIATION 26.75 • n=7 Participants
|
124.26 mmHg
STANDARD_DEVIATION 26.36 • n=5 Participants
|
124.11 mmHg
STANDARD_DEVIATION 25.14 • n=5 Participants
|
|
Diastolic Blood Pressure
|
67.48 mmHg
STANDARD_DEVIATION 16.09 • n=7 Participants
|
67.45 mmHg
STANDARD_DEVIATION 16.87 • n=5 Participants
|
67.34 mmHg
STANDARD_DEVIATION 16.87 • n=5 Participants
|
|
Heart Rate
|
71.89 Beats Per minute
STANDARD_DEVIATION 13.12 • n=7 Participants
|
71.54 Beats Per minute
STANDARD_DEVIATION 13.67 • n=5 Participants
|
71.26 Beats Per minute
STANDARD_DEVIATION 13.87 • n=5 Participants
|
|
Hemoglobin
|
12.14 grams per deciliter
STANDARD_DEVIATION 2.69 • n=7 Participants
|
12.25 grams per deciliter
STANDARD_DEVIATION 2.83 • n=5 Participants
|
12.37 grams per deciliter
STANDARD_DEVIATION 2.83 • n=5 Participants
|
|
Hematocrit
|
36.16 percentage
STANDARD_DEVIATION 7.71 • n=7 Participants
|
38.15 percentage
STANDARD_DEVIATION 26.52 • n=5 Participants
|
40.18 percentage
STANDARD_DEVIATION 26.52 • n=5 Participants
|
|
Platelet Count
|
221.81 platelets per micro liter of blood
STANDARD_DEVIATION 99.45 • n=7 Participants
|
217.36 platelets per micro liter of blood
STANDARD_DEVIATION 92.5 • n=5 Participants
|
212.83 platelets per micro liter of blood
STANDARD_DEVIATION 92.5 • n=5 Participants
|
|
Type of Surgery
Abdominal Surgery
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
35 Participants
n=5 Participants
|
|
Type of Surgery
Thoracic Surgery
|
38 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
32 Participants
n=5 Participants
|
|
Type of Surgery
Vascular Surgery
|
43 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
51 Participants
n=5 Participants
|
|
Lewis Bleeding Scale Grade
Lewis Bleeding Scale Grade 1
|
73 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
61 Participants
n=5 Participants
|
|
Lewis Bleeding Scale Grade
Lewis Bleeding Scale Grade 2
|
45 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutesThe time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point.
Outcome measures
| Measure |
HemoStyp
n=118 Participants
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
n=118 Participants
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period.
|
36 seconds
Interval 31.0 to 47.0
|
67 seconds
Interval 57.0 to 89.0
|
SECONDARY outcome
Timeframe: Between 2 minutes and 10 minutesPercentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment.
Outcome measures
| Measure |
HemoStyp
n=118 Participants
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
n=118 Participants
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
2 minutes
|
118 Participants
|
96 Participants
|
|
Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
5 minutes
|
118 Participants
|
110 Participants
|
|
Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
10 minutes
|
118 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: Intraoperative periodPercentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period. The intraoperative period started when the first cut was made to the patient and ended when the operative field was closed and dressed.
Outcome measures
| Measure |
HemoStyp
n=118 Participants
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
n=118 Participants
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site
|
118 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: Intraoperative period post hemostasisPopulation: 6 subjects in the Surgicel cohort could not be analyzed because hemostasis was never obtained at the target bleeding site.
Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis
Outcome measures
| Measure |
HemoStyp
n=118 Participants
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
n=112 Participants
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 3 subjects in the HemoStyp cohort and 6 subjects in the Surgicel cohort did not finish the 30 day follow up so they were not included in the analysis population.
Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery.
Outcome measures
| Measure |
HemoStyp
n=115 Participants
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
n=112 Participants
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site
|
0 Participants
|
0 Participants
|
Adverse Events
HemoStyp
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Surgicel
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
HemoStyp
n=118 participants at risk
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
n=118 participants at risk
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.85%
1/118 • Number of events 1 • From treatment to 30 days.
|
0.00%
0/118 • From treatment to 30 days.
|
|
Skin and subcutaneous tissue disorders
Soft Tissue infection
|
0.85%
1/118 • Number of events 1 • From treatment to 30 days.
|
0.00%
0/118 • From treatment to 30 days.
|
Other adverse events
| Measure |
HemoStyp
n=118 participants at risk
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
|
Surgicel
n=118 participants at risk
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/118 • From treatment to 30 days.
|
0.85%
1/118 • Number of events 1 • From treatment to 30 days.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/118 • From treatment to 30 days.
|
0.85%
1/118 • Number of events 1 • From treatment to 30 days.
|
|
Vascular disorders
Bleeding Anterior Venous Fistula
|
0.00%
0/118 • From treatment to 30 days.
|
0.85%
1/118 • Number of events 1 • From treatment to 30 days.
|
|
Blood and lymphatic system disorders
Seroma
|
0.00%
0/118 • From treatment to 30 days.
|
0.85%
1/118 • Number of events 1 • From treatment to 30 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/118 • From treatment to 30 days.
|
0.85%
1/118 • Number of events 1 • From treatment to 30 days.
|
Additional Information
Gerard Abate, MD Chief Medical Officer
United Health Products, Inc.
Phone: (386) 627-1598
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place