Trial Outcomes & Findings for Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries (NCT NCT01754480)
NCT ID: NCT01754480
Last Updated: 2017-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
From start of treatment until 4 minutes after treatment start
Results posted on
2017-02-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Part I + Part II (Overall Study)
STARTED
|
163
|
162
|
|
Part I + Part II (Overall Study)
Completed Study up to Week 6
|
147
|
153
|
|
Part I + Part II (Overall Study)
COMPLETED
|
138
|
139
|
|
Part I + Part II (Overall Study)
NOT COMPLETED
|
25
|
23
|
|
Primary Part II
STARTED
|
111
|
113
|
|
Primary Part II
Completed Study up to Week 6
|
100
|
108
|
|
Primary Part II
COMPLETED
|
96
|
102
|
|
Primary Part II
NOT COMPLETED
|
15
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
Baseline characteristics by cohort
| Measure |
Fibrin Sealant Grifols
n=163 Participants
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.
|
Surgicel®
n=162 Participants
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.
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.82 years
STANDARD_DEVIATION 13.753 • n=5 Participants
|
57.04 years
STANDARD_DEVIATION 15.194 • n=7 Participants
|
57.93 years
STANDARD_DEVIATION 14.494 • n=5 Participants
|
|
Age, Customized
<=11 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
Between 12 and 17 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 64 years
|
100 participants
n=5 Participants
|
101 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
61 participants
n=5 Participants
|
58 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Gender
Female
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Gender
Male
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=5 Participants
|
91 participants
n=7 Participants
|
179 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
53 participants
n=5 Participants
|
50 participants
n=7 Participants
|
103 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until 4 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
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.
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=111 Participants
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.
|
Surgicel®
n=113 Participants
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.
|
|---|---|---|
|
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
|
92.8 Percent of subjects achieving hemostasis
|
80.5 Percent of subjects achieving hemostasis
|
SECONDARY outcome
Timeframe: From start of treatment until 3 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
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.
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=111 Participants
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.
|
Surgicel®
n=113 Participants
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.
|
|---|---|---|
|
Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start
|
85.6 Percent of subjects achieving hemostasis
|
62.8 Percent of subjects achieving hemostasis
|
SECONDARY outcome
Timeframe: From start of treatment until 10 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=111 Participants
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.
|
Surgicel®
n=113 Participants
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.
|
|---|---|---|
|
Time to Hemostasis
|
2.0 minutes
Interval 2.0 to 3.0
|
3.0 minutes
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: From start of treatment until 10 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
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
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=111 Participants
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.
|
Surgicel®
n=113 Participants
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.
|
|---|---|---|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 2 minutes
|
55.9 Percent of subjects achieving hemostasis
|
41.6 Percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 5 minutes
|
97.3 Percent of subjects achieving hemostasis
|
85.0 Percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 7 minutes
|
97.3 Percent of subjects achieving hemostasis
|
87.6 Percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 10 minutes
|
98.2 Percent of subjects achieving hemostasis
|
92.0 Percent of subjects achieving hemostasis
|
SECONDARY outcome
Timeframe: From start of treatment until 10 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
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.
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=111 Participants
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.
|
Surgicel®
n=113 Participants
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.
|
|---|---|---|
|
Prevalence of Treatment Failures
|
7.2 percent of subjects
|
19.5 percent of subjects
|
Adverse Events
Fibrin Sealant Grifols
Serious events: 30 serious events
Other events: 131 other events
Deaths: 0 deaths
Surgicel®
Serious events: 23 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fibrin Sealant Grifols
n=163 participants at risk
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.
|
Surgicel®
n=162 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.2%
2/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Bradycardia
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Cardiac arrest
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Abdominal pain
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Ileus
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Device occlusion
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Extravasation
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Fatigue
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Multi-organ failure
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Pyrexia
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Hepatobiliary disorders
Biloma
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Hepatobiliary disorders
Hepatic failure
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Abdominal abscess
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.2%
2/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Clostridium difficile colitis
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Liver abscess
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Pneumonia
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Postoperative wound infection
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Sepsis
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Sepsis syndrome
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Septic shock
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.2%
2/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Wound infection
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
2.5%
4/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.2%
2/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Brain injury
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Loss of consciousness
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Syncope
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Psychiatric disorders
Delirium
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Renal and urinary disorders
Renal failure
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
3/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
4/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
3/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
3/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Surgical and medical procedures
Lung operation
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
3/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Embolism
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Hypotension
|
1.2%
2/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.62%
1/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Shock
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Vena cava thrombosis
|
0.61%
1/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
Other adverse events
| Measure |
Fibrin Sealant Grifols
n=163 participants at risk
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.
|
Surgicel®
n=162 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.9%
21/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
16.0%
26/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Tachycardia
|
8.6%
14/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
14.8%
24/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
10/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.9%
3/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Constipation
|
12.3%
20/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
14.2%
23/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Nausea
|
20.9%
34/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
23.5%
38/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
13/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
10.5%
17/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Oedema peripheral
|
8.6%
14/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
6.8%
11/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Pyrexia
|
9.8%
16/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
11.7%
19/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Incision site pain
|
7.4%
12/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
6.8%
11/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
5.5%
9/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
2.5%
4/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Procedural pain
|
36.2%
59/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
37.7%
61/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
6/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
6.8%
11/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.7%
6/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
6.8%
11/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.9%
8/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
9.3%
15/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.7%
11/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
6.2%
10/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
3/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
6.8%
11/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
11/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
5.6%
9/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
12/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
7.4%
12/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Hypertension
|
8.6%
14/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
7.4%
12/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Hypotension
|
12.9%
21/163 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
5.6%
9/162 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER