Trial Outcomes & Findings for U.S. Study of Fibrocaps in Surgical Hemostasis (NCT NCT01256164)
NCT ID: NCT01256164
Last Updated: 2017-09-13
Results Overview
Time to hemostasis recorded from the first application of study treatment until cessation of bleeding
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
0-10 minutes
Results posted on
2017-09-13
Participant Flow
Enrollment commenced in February 2011 and completed in October 2011 at 8 investigative study sites in the United States.
Approximately 90 eligible subjects were planned for enrollment, randomization, and treatment. The enrollment stopped short of the targeted 90 subjects due to enrollment of more subjects in the parallel study being conducted in the Netherlands.
Participant milestones
| Measure |
Fibrocaps + Gelfoam
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
23
|
|
Overall Study
COMPLETED
|
47
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
U.S. Study of Fibrocaps in Surgical Hemostasis
Baseline characteristics by cohort
| Measure |
Fibrocaps + Gelfoam
n=47 Participants
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 Participants
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 13.97 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
23 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-10 minutesPopulation: All subjects treated with a time to hemostasis were included in the analysis
Time to hemostasis recorded from the first application of study treatment until cessation of bleeding
Outcome measures
| Measure |
Fibrocaps + Gelfoam
n=47 Participants
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 Participants
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Mean Time to Hemostasis (TTH)
|
1.9 minutes
Standard Deviation 1.3
|
4.8 minutes
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 28 DaysPopulation: All subjects treated were analyzed for safety.
Number of participants with Adverse events and clinically-significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the TBS
Outcome measures
| Measure |
Fibrocaps + Gelfoam
n=47 Participants
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 Participants
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Safety
|
47 participants
|
23 participants
|
SECONDARY outcome
Timeframe: 3 minutesOutcome measures
| Measure |
Fibrocaps + Gelfoam
n=47 Participants
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 Participants
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Number of Subjects Achieving Hemostasis at 3 Minutes
|
39 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 5 minutesOutcome measures
| Measure |
Fibrocaps + Gelfoam
n=47 Participants
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 Participants
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Number of Participants Achieving Hemostasis at 5 Minutes
|
44 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 10 minutesOutcome measures
| Measure |
Fibrocaps + Gelfoam
n=47 Participants
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 Participants
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Number of Patients Achieving Hemostasis at 10 Minutes
|
47 participants
|
18 participants
|
Adverse Events
Fibrocaps + Gelfoam
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
Gelfoam
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fibrocaps + Gelfoam
n=47 participants at risk
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 participants at risk
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/47 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Infections and infestations
Cellulitis
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emobolism
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Infections and infestations
Herpes zoster
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/47 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
4.3%
1/23 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Vascular disorders
Hypotension
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Vascular disorders
Deep cenous thrombosis
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Injury, poisoning and procedural complications
Scrotal hematoma
|
0.00%
0/47 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
4.3%
1/23 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
Other adverse events
| Measure |
Fibrocaps + Gelfoam
n=47 participants at risk
After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
|
Gelfoam
n=23 participants at risk
Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.5%
12/47 • Number of events 12 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
21.7%
5/23 • Number of events 5 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
31.9%
15/47 • Number of events 15 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
39.1%
9/23 • Number of events 9 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
8/47 • Number of events 8 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
8.7%
2/23 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
General disorders
Oedema peripheral
|
12.8%
6/47 • Number of events 6 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
8.7%
2/23 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
General disorders
Pyrexia
|
6.4%
3/47 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
21.7%
5/23 • Number of events 5 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Injury, poisoning and procedural complications
Incision site pain
|
6.4%
3/47 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
8.7%
2/23 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
53.2%
25/47 • Number of events 25 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
52.2%
12/23 • Number of events 12 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/47 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
13.0%
3/23 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.4%
3/47 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.1%
9/47 • Number of events 9 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
17.4%
4/23 • Number of events 4 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.5%
4/47 • Number of events 4 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.9%
7/47 • Number of events 7 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
8.7%
2/23 • Number of events 26 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Nervous system disorders
Headache
|
12.8%
6/47 • Number of events 6 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
4.3%
1/23 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Nervous system disorders
Hypoaesthesia
|
8.5%
4/47 • Number of events 4 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
0.00%
0/23 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
8.7%
2/23 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Psychiatric disorders
Insomnia
|
6.4%
3/47 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
4.3%
1/23 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
1/47 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
8.7%
2/23 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
3/47 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
4.3%
1/23 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
|
Vascular disorders
Hypotension
|
4.3%
2/47 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
8.7%
2/23 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators were part of the primary publication. Each investigator may publish on the data from subjects enrolled at their site after the initial publication has been submitted.
- Publication restrictions are in place
Restriction type: OTHER