Trial Outcomes & Findings for A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue (NCT NCT01719172)
NCT ID: NCT01719172
Last Updated: 2014-02-27
Results Overview
Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Intra-operative (Day 0)
Results posted on
2014-02-27
Participant Flow
Subjects who were scheduled for non-emergent, soft tissue procedures performed via an open approach were assessed for potential study eligibility via a screening/baseline assessment performed within 30 days of their scheduled procedure.
Subjects who met the pre-operative eligibility criteria were considered for study participation. During the surgical procedures, subjects who met the intra-operative eligibility criteria were enrolled into the study. Subjects who did not meet all criteria were considered screen failures and not enrolled.
Participant milestones
| Measure |
Veriset™ Hemostatic Patch
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Veriset™ Hemostatic Patch
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
Baseline characteristics by cohort
| Measure |
Veriset™ Hemostatic Patch
n=30 Participants
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Height
|
174.0 centimeters
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Weight
|
75.0 kilograms
STANDARD_DEVIATION 19.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Intra-operative (Day 0)Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Outcome measures
| Measure |
Veriset™ Hemostatic Patch
n=30 Participants
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
|
29 participants
|
SECONDARY outcome
Timeframe: Intra-operative (Day 0)Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Outcome measures
| Measure |
Veriset™ Hemostatic Patch
n=30 Participants
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Proportion of Subjects Who Achieve Hemostasis Within 1 Minute
|
21 participants
Interval 50.6 to 85.3
|
SECONDARY outcome
Timeframe: Intra-operative (Day 0)Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Outcome measures
| Measure |
Veriset™ Hemostatic Patch
n=30 Participants
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Median Time to Achieve Hemostasis
|
1 Minutes
Interval 0.5 to 1.0
|
Adverse Events
Veriset™ Hemostatic Patch
Serious events: 11 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Veriset™ Hemostatic Patch
n=30 participants at risk
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Sick sinus syndrome
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Tachyarrhythmia
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Gastrointestinal disorders
Mesenteric haemorrhage
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
General disorders
Impaired healing
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Hepatobiliary disorders
Hepatic failure
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Bacterial diarrhoea
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Neutropenic sepsis
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Investigations
Laboratory test abnormal
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Renal and urinary disorders
Renal failure
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Vascular disorders
Haemorrhage
|
3.3%
1/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
Other adverse events
| Measure |
Veriset™ Hemostatic Patch
n=30 participants at risk
Subjects received the topical hemostat Veriset™ Hemostatic Patch
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
4/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Gastrointestinal disorders
Duodenitis
|
6.7%
2/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
4/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
General disorders
Impaired healing
|
13.3%
4/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Injury, poisoning and procedural complications
Seroma
|
6.7%
2/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Investigations
Hepatic enzyme increased
|
6.7%
2/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Metabolism and nutrition disorders
Fluid retention
|
6.7%
2/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
3/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
2/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
4/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
2/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Vascular disorders
Haematoma
|
6.7%
2/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Vascular disorders
Hypertension
|
10.0%
3/30 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place