Trial Outcomes & Findings for A Study of Fibrocaps in Liver Surgery in the Netherlands (NCT NCT01256190)

NCT ID: NCT01256190

Last Updated: 2016-08-22

Results Overview

Time from application of treatment to cessation of bleeding

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: 0-10 minutes
• Results posted on: 2016-08-22

Participant Flow

Enrollment commenced in December 2010 and completed in October 2011 from 5 academic medical centers in the Netherlands

Participant milestones

Measure	Fibrocaps + Gelatin Sponge Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge approved device for surgical bleeding
Overall Study STARTED	39	17
Overall Study COMPLETED	37	17
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Fibrocaps + Gelatin Sponge Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge approved device for surgical bleeding
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

A Study of Fibrocaps in Liver Surgery in the Netherlands

Baseline characteristics by cohort

Measure	Fibrocaps + Gelatin Sponge n=39 Participants Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 Participants approved device for surgical bleeding	Total n=56 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	23 Participants n=5 Participants	11 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 13 • n=5 Participants	64 years STANDARD_DEVIATION 9 • n=7 Participants	61 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	11 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Netherlands	39 participants n=5 Participants	17 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-10 minutes

Population: All subjects treated with a time to hemostasis were included in the analysis

Time from application of treatment to cessation of bleeding

Outcome measures

Measure	Fibrocaps + Gelatin Sponge n=39 Participants Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 Participants approved device for surgical bleeding
Time to Hemostasis	2.2 minutes Standard Deviation 1.2	4.4 minutes Standard Deviation 3.1

SECONDARY outcome

Timeframe: 28 days

Population: All subjects treated were analyzed for safety. There were 39 subjects treated with Fibrocaps and 16 treated with gelatin sponge only, since 1 gel sponge subject was randomized but not treated.

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 target bleeding site (TBS)

Outcome measures

Measure	Fibrocaps + Gelatin Sponge n=39 Participants Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 Participants approved device for surgical bleeding
Safety	31 participants	10 participants

SECONDARY outcome

Timeframe: 5 minutes

Number of subjects in each group that achieved hemostasis at pre-specified times after treatment

Outcome measures

Measure	Fibrocaps + Gelatin Sponge n=39 Participants Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 Participants approved device for surgical bleeding
Incidence of Hemostasis at 5 Minutes	37 participants	12 participants

SECONDARY outcome

Timeframe: 3 minutes

Outcome measures

Measure	Fibrocaps + Gelatin Sponge n=39 Participants Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 Participants approved device for surgical bleeding
Number of Subjects Achieving Hemostasis at 3 Minutes	30 participants	9 participants

SECONDARY outcome

Timeframe: 10 minutes

Outcome measures

Measure	Fibrocaps + Gelatin Sponge n=39 Participants Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 Participants approved device for surgical bleeding
Number of Patients Achieving Hemostasis at 10 Minutes	39 participants	14 participants

Adverse Events

Fibrocaps + Gelatin Sponge

Serious events: 11 serious events

Other events: 31 other events

Deaths: 0 deaths

Gelatin Sponge

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fibrocaps + Gelatin Sponge n=39 participants at risk Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 participants at risk approved device for surgical bleeding
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastases to bone	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Infections and infestations peritoneal infection	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Hepatobiliary disorders hepatic failure	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
General disorders pyrexia	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Injury, poisoning and procedural complications post procedural bile leak	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Psychiatric disorders delirium	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Respiratory, thoracic and mediastinal disorders pleural effusion	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	11.8% 2/17 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
General disorders edema	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Respiratory, thoracic and mediastinal disorders aspiration	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Cardiac disorders acute coronary syndrome	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Cardiac disorders ventricular tachycardia	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Cardiac disorders cardiac arrest	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Infections and infestations pneumonia	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Renal and urinary disorders renal tubular necrosis	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Gastrointestinal disorders ileus	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Nervous system disorders cerebrovascular accident	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Cardiac disorders congestive cardiac failure	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Injury, poisoning and procedural complications Anastomotic leak	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment

Other adverse events

Measure	Fibrocaps + Gelatin Sponge n=39 participants at risk Topical Fibrocaps powder followed by application of gelatin sponge	Gelatin Sponge n=17 participants at risk approved device for surgical bleeding
Gastrointestinal disorders Constipation	23.1% 9/39 • Number of events 9 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	23.5% 4/17 • Number of events 4 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Metabolism and nutrition disorders potassium deficiency	15.4% 6/39 • Number of events 6 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
General disorders fever	10.3% 4/39 • Number of events 4 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Gastrointestinal disorders gastric retention	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Gastrointestinal disorders nausea	15.4% 6/39 • Number of events 6 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	23.5% 4/17 • Number of events 5 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Blood and lymphatic system disorders anaemia	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Cardiac disorders bradycardia	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Gastrointestinal disorders abdonminal pain	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Gastrointestinal disorders diarrhoea	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Infections and infestations urinary tract infection	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Infections and infestations wound infection	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Injury, poisoning and procedural complications procedural pain	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Investigations low potassium	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Investigations haemoglobin decreased	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Investigations hepatic enzyme increased	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Investigations neutrophil count increased	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Psychiatric disorders anxiety	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Psychiatric disorders insomnia	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Renal and urinary disorders renal impairment	2.6% 1/39 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Respiratory, thoracic and mediastinal disorders dyspnoea	5.1% 2/39 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	0.00% 0/17 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Respiratory, thoracic and mediastinal disorders hiccups	0.00% 0/39 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment	5.9% 1/17 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected for 28 days post treatment

Additional Information

Lawrence Hill

Mallinckrodt

Phone: 908-238-6370

Email: lawrence.hill@mallinckrodt.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigators will be 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