Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.
This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrocaps + Gelatin sponge | Experimental | Topical Fibrocaps powder followed by application of gelatin sponge |
|
| Gelatin Sponge | Active Comparator | approved device for surgical bleeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrocaps (fibrin sealant) | Biological | human thrombin and fibrinogen topical powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | Time from application of treatment to cessation of bleeding | 0-10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 target bleeding site (TBS) | 28 days |
| Incidence of Hemostasis at 5 Minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Frohna, MD, PhD | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38695613 | Derived | Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2. |
Not provided
Not provided
Not provided
Enrollment commenced in December 2010 and completed in October 2011 from 5 academic medical centers in the Netherlands
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fibrocaps + Gelatin Sponge | Topical Fibrocaps powder followed by application of gelatin sponge |
| FG001 | Gelatin Sponge | approved device for surgical bleeding |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fibrocaps + Gelatin Sponge | Topical Fibrocaps powder followed by application of gelatin sponge |
| BG001 | Gelatin Sponge | approved device for surgical bleeding |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Hemostasis | Time from application of treatment to cessation of bleeding | All subjects treated with a time to hemostasis were included in the analysis | Posted | Mean | Standard Deviation | minutes | 0-10 minutes |
|
Treatment emergent Adverse Events (AE) were collected for 28 days post treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibrocaps + Gelatin Sponge | Topical Fibrocaps powder followed by application of gelatin sponge |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Hill | Mallinckrodt | 908-238-6370 | lawrence.hill@mallinckrodt.com |
Not provided
| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gelatin sponge | Device | absorbable gelatin sponge for topical use |
|
|
Number of subjects in each group that achieved hemostasis at pre-specified times after treatment |
| 5 minutes |
| Number of Subjects Achieving Hemostasis at 3 Minutes | 3 minutes |
| Number of Patients Achieving Hemostasis at 10 Minutes | 10 minutes |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | 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 target bleeding site (TBS) | 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. | Posted | Number | participants | 28 days |
|
|
|
|
| Secondary | Incidence of Hemostasis at 5 Minutes | Number of subjects in each group that achieved hemostasis at pre-specified times after treatment | Posted | Number | participants | 5 minutes |
|
|
|
|
| Secondary | Number of Subjects Achieving Hemostasis at 3 Minutes | Posted | Number | participants | 3 minutes |
|
|
|
|
| Secondary | Number of Patients Achieving Hemostasis at 10 Minutes | Posted | Number | participants | 10 minutes |
|
|
|
|
| 11 |
| 39 |
| 31 |
| 39 |
| EG001 | Gelatin Sponge | approved device for surgical bleeding | 3 | 17 | 10 | 17 |
| peritoneal infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| hepatic failure | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
|
| pyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| delirium | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| edema | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| acute coronary syndrome | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| ventricular tachycardia | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| cardiac arrest | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| renal tubular necrosis | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
|
| ileus | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| cerebrovascular accident | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| congestive cardiac failure | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | Anastomotic leak | Systematic Assessment |
|
| potassium deficiency | Metabolism and nutrition disorders | Hypokalaemia | Systematic Assessment |
|
| fever | General disorders | pyrexia | Systematic Assessment |
|
| gastric retention | Gastrointestinal disorders | impaired gastric emp | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| bradycardia | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| abdonminal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| wound infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| procedural pain | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| low potassium | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| haemoglobin decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| hepatic enzyme increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| neutrophil count increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| renal impairment | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
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.
| D015503 |
| Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |