Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols... | NCT01754480

Label	Type	Description	Intervention Names
Fibrin Sealant Grifols	Experimental	Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).	Biological: Fibrin Sealant Grifols
Surgicel®	Active Comparator	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.	Device: Surgicel®

Name	Type	Description	Arm Group Labels	Other Names
Fibrin Sealant Grifols	Biological	Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.

Measure	Description	Time Frame
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start	Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.	From start of treatment until 4 minutes after treatment start

Measure	Description	Time Frame
Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start	Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.	From start of treatment until 3 minutes after treatment start

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
A target bleeding site can be identified.
Target bleeding site is identified on the cut raw liver surface (resection area).
Target bleeding site has moderate bleeding according to the Investigator's judgment.

Exclusion Criteria:

Require hepatic resection due to trauma.
Infection in the anatomic surgical area.
History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component.
Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
Receiving an organ transplant during the same surgical procedure.
Undergone a therapeutic surgical procedure within 30 days from the screening visit.
A target bleeding site cannot be identified.
The target bleeding site has a mild or severe bleeding.
Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.

Facility	Status	City	State	ZIP	Country	Contacts
224		Loma Linda	California	92354	United States
214

ID	Title	Description
FG000	Fibrin Sealant Grifols	Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
FG001	Surgicel®

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

Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start

Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.

Efficacy analysis was performed on subjects in the Primary Part (II) of the study

Posted

Number

Percent of subjects achieving hemostasis

From start of treatment until 4 minutes after treatment start

ID	Title	Description
OG000	Fibrin Sealant Grifols	Fibrin Sealant Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
OG001	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Units	Counts
Participants	OG000111 OG001113

Title

Denominators

Categories

Title	Measurements
	OG00092.8 OG00180.5

Secondary

Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start

Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.

Efficacy analysis was performed on subjects in the Primary Part (II) of the study

Posted

Number

Percent of subjects achieving hemostasis

From start of treatment until 3 minutes after treatment start

ID	Title	Description
OG000	Fibrin Sealant Grifols	Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
OG001	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Units	Counts
Participants

Secondary

Time to Hemostasis

Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.

Efficacy analysis was performed on subjects in the Primary Part (II) of the study

Posted

Median

95% Confidence Interval

minutes

From start of treatment until 10 minutes after treatment start

ID	Title	Description
OG000	Fibrin Sealant Grifols	Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
OG001	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Units	Counts
Participants

Secondary

Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points

Cumulative proportion of subjects having achieved hemostasis by each of the following time points:

At 2 minutes following start of study treatment
At 5 minutes following start of study treatment
At 7 minutes following start of study treatment
At 10 minutes following start of study treatment

Efficacy analysis was performed on subjects in the Primary Part (II) of the study

Posted

Number

Percent of subjects achieving hemostasis

From start of treatment until 10 minutes after treatment start

ID	Title	Description
OG000	Fibrin Sealant Grifols	Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
OG001	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Units	Counts

Secondary

Prevalence of Treatment Failures

Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.

Efficacy analysis was performed on subjects in the Primary Part (II) of the study

Posted

Number

percent of subjects

From start of treatment until 10 minutes after treatment start

ID	Title	Description
OG000	Fibrin Sealant Grifols	Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
OG001	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Febrile neutropenia	Blood and lymphatic system disorders	EG0001 affected163 at risk EG0011 affected162 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Atrial fibrillation	Cardiac disorders	EG0001 affected163 at risk EG0012 affected162 at risk
Bradycardia	Cardiac disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Cardiac arrest	Cardiac disorders	EG0001 affected163 at risk EG0011 affected162 at risk
Cardiac failure congestive	Cardiac disorders	EG0002 affected163 at risk EG0010 affected162 at risk
Congestive cardiomyopathy	Cardiac disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Abdominal pain	Gastrointestinal disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Ascites	Gastrointestinal disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Ileus	Gastrointestinal disorders	EG0002 affected163 at risk EG0010 affected162 at risk
Intestinal perforation	Gastrointestinal disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	EG0002 affected163 at risk EG0010 affected162 at risk
Small intestinal obstruction	Gastrointestinal disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Device occlusion	General disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Extravasation	General disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Fatigue	General disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Multi-organ failure	General disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Pyrexia	General disorders	EG0001 affected163 at risk EG0011 affected162 at risk
Biloma	Hepatobiliary disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Hepatic failure	Hepatobiliary disorders	EG0002 affected163 at risk EG0011 affected162 at risk
Hepatic necrosis	Hepatobiliary disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Ischaemic hepatitis	Hepatobiliary disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Portal vein thrombosis	Hepatobiliary disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Abdominal abscess	Infections and infestations	EG0001 affected163 at risk EG0012 affected162 at risk
Clostridium difficile colitis	Infections and infestations	EG0001 affected163 at risk EG0010 affected162 at risk
Enterovirus infection	Infections and infestations	EG0000 affected163 at risk EG0011 affected162 at risk
Liver abscess	Infections and infestations	EG0002 affected163 at risk EG0010 affected162 at risk
Pneumonia	Infections and infestations	EG0002 affected163 at risk EG0010 affected162 at risk
Postoperative wound infection	Infections and infestations	EG0001 affected163 at risk EG0010 affected162 at risk
Rhinovirus infection	Infections and infestations	EG0000 affected163 at risk EG0011 affected162 at risk
Sepsis	Infections and infestations	EG0002 affected163 at risk EG0011 affected162 at risk
Sepsis syndrome	Infections and infestations	EG0001 affected163 at risk EG0010 affected162 at risk
Septic shock	Infections and infestations	EG0001 affected163 at risk EG0010 affected162 at risk
Upper respiratory tract infection	Infections and infestations	EG0000 affected163 at risk EG0012 affected162 at risk
Wound infection	Infections and infestations	EG0001 affected163 at risk EG0010 affected162 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	EG0001 affected163 at risk EG0010 affected162 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	EG0004 affected163 at risk EG0012 affected162 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	EG0001 affected163 at risk EG0011 affected162 at risk
Venous injury	Injury, poisoning and procedural complications	EG0000 affected163 at risk EG0011 affected162 at risk
Wound evisceration	Injury, poisoning and procedural complications	EG0001 affected163 at risk EG0010 affected162 at risk
Electrocardiogram ST segment abnormal	Investigations	EG0001 affected163 at risk EG0010 affected162 at risk
Dehydration	Metabolism and nutrition disorders	EG0002 affected163 at risk EG0011 affected162 at risk
Failure to thrive	Metabolism and nutrition disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Gout	Metabolism and nutrition disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected163 at risk EG0010 affected162 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected163 at risk EG0011 affected162 at risk
Brain injury	Nervous system disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Loss of consciousness	Nervous system disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Neuralgia	Nervous system disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Syncope	Nervous system disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Transient ischaemic attack	Nervous system disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Delirium	Psychiatric disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Renal failure	Renal and urinary disorders	EG0001 affected163 at risk EG0011 affected162 at risk
Renal failure acute	Renal and urinary disorders	EG0003 affected163 at risk EG0010 affected162 at risk
Urinary retention	Renal and urinary disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0004 affected163 at risk EG0011 affected162 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG0003 affected163 at risk EG0011 affected162 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0003 affected163 at risk EG0011 affected162 at risk
Lung operation	Surgical and medical procedures	EG0001 affected163 at risk EG0010 affected162 at risk
Deep vein thrombosis	Vascular disorders	EG0003 affected163 at risk EG0011 affected162 at risk
Embolism	Vascular disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Haemorrhage	Vascular disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Hypertensive crisis	Vascular disorders	EG0000 affected163 at risk EG0011 affected162 at risk
Hypotension	Vascular disorders	EG0002 affected163 at risk EG0011 affected162 at risk
Shock	Vascular disorders	EG0001 affected163 at risk EG0010 affected162 at risk
Vena cava thrombosis	Vascular disorders	EG0001 affected163 at risk EG0010 affected162 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG00021 affected163 at risk EG00126 affected162 at risk
Tachycardia	Cardiac disorders	EG00014 affected163 at risk EG00124 affected162 at risk
Abdominal pain	Gastrointestinal disorders	EG00010 affected163 at risk EG0013 affected162 at risk
Constipation	Gastrointestinal disorders	EG00020 affected163 at risk EG00123 affected162 at risk
Nausea	Gastrointestinal disorders	EG00034 affected163 at risk EG00138 affected162 at risk
Vomiting	Gastrointestinal disorders	EG00013 affected163 at risk EG00117 affected162 at risk
Oedema peripheral	General disorders	EG00014 affected163 at risk EG00111 affected162 at risk
Pyrexia	General disorders	EG00016 affected163 at risk EG00119 affected162 at risk
Incision site pain	Injury, poisoning and procedural complications	EG00012 affected163 at risk EG00111 affected162 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	EG0009 affected163 at risk EG0014 affected162 at risk
Procedural pain	Injury, poisoning and procedural complications	EG00059 affected163 at risk EG00161 affected162 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0006 affected163 at risk EG00111 affected162 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0006 affected163 at risk EG00111 affected162 at risk
Hypophosphataemia	Metabolism and nutrition disorders	EG0008 affected163 at risk EG00115 affected162 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	EG00011 affected163 at risk EG00110 affected162 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0003 affected163 at risk EG00111 affected162 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG00011 affected163 at risk EG0019 affected162 at risk
Pruritus	Skin and subcutaneous tissue disorders	EG00012 affected163 at risk EG00112 affected162 at risk
Hypertension	Vascular disorders	EG00014 affected163 at risk EG00112 affected162 at risk
Hypotension	Vascular disorders	EG00021 affected163 at risk EG0019 affected162 at risk

ID	Title	Description
BG000	Fibrin Sealant Grifols	Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
BG001	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fibrin Sealant Grifols	Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.			30	163	131	163
EG001	Surgicel®	Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.			23	162	136	162