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Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

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ClinicalTrials.gov Identifier: NCT01754480
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals, LLC ( Instituto Grifols, S.A. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Parenchymous Tissue Surgical Bleeding
Interventions Biological: Fibrin Sealant Grifols
Device: Surgicel®
Enrollment 325
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fibrin Sealant Grifols Surgicel®
Hide Arm/Group Description 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® 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.
Period Title: Part I + Part II (Overall Study)
Started 163 162
Completed Study up to Week 6 147 153
Completed 138 [1] 139 [2]
Not Completed 25 23
[1]
Completed Virology follow-up visit at Month 3 or Month 6 (not required for 2 pediatric subjects)
[2]
Completed Virology follow-up visit at Month 3 or Month 6 (not required for 3 pediatric subjects)
Period Title: Primary Part II
Started 111 113
Completed Study up to Week 6 100 108
Completed 96 [1] 102 [1]
Not Completed 15 11
[1]
Completed Virology follow-up visit at Month 3 or Month 6 (not required for pediatric subjects)
Arm/Group Title Fibrin Sealant Grifols Surgicel® Total
Hide Arm/Group Description 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® 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 of all reporting groups
Overall Number of Baseline Participants 163 162 325
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 162 participants 325 participants
58.82  (13.753) 57.04  (15.194) 57.93  (14.494)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 162 participants 325 participants
<=11 years 2 1 3
Between 12 and 17 years 0 2 2
Between 18 and 64 years 100 101 201
>=65 years 61 58 119
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 162 participants 325 participants
Female
78
  47.9%
77
  47.5%
155
  47.7%
Male
85
  52.1%
85
  52.5%
170
  52.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 162 participants 325 participants
Russian Federation 3 2 5
Hungary 19 19 38
United States 88 91 179
Serbia 53 50 103
1.Primary Outcome
Title Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Hide Description 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.
Time Frame From start of treatment until 4 minutes after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Arm/Group Title Fibrin Sealant Grifols Surgicel®
Hide Arm/Group Description:
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® 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.
Overall Number of Participants Analyzed 111 113
Measure Type: Number
Unit of Measure: Percent of subjects achieving hemostasis
92.8 80.5
2.Secondary Outcome
Title Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start
Hide Description 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.
Time Frame From start of treatment until 3 minutes after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Arm/Group Title Fibrin Sealant Grifols Surgicel®
Hide Arm/Group Description:
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® 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.
Overall Number of Participants Analyzed 111 113
Measure Type: Number
Unit of Measure: Percent of subjects achieving hemostasis
85.6 62.8
3.Secondary Outcome
Title Time to Hemostasis
Hide Description Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
Time Frame From start of treatment until 10 minutes after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Arm/Group Title Fibrin Sealant Grifols Surgicel®
Hide Arm/Group Description:
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® 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.
Overall Number of Participants Analyzed 111 113
Median (95% Confidence Interval)
Unit of Measure: minutes
2.0
(2.00 to 3.00)
3.0
(2.00 to 3.00)
4.Secondary Outcome
Title Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hide Description

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
Time Frame From start of treatment until 10 minutes after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Arm/Group Title Fibrin Sealant Grifols Surgicel®
Hide Arm/Group Description:
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® 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.
Overall Number of Participants Analyzed 111 113
Measure Type: Number
Unit of Measure: Percent of subjects achieving hemostasis
Hemostasis by 2 minutes 55.9 41.6
Hemostasis by 5 minutes 97.3 85.0
Hemostasis by 7 minutes 97.3 87.6
Hemostasis by 10 minutes 98.2 92.0
5.Secondary Outcome
Title Prevalence of Treatment Failures
Hide Description 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.
Time Frame From start of treatment until 10 minutes after treatment start
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Arm/Group Title Fibrin Sealant Grifols Surgicel®
Hide Arm/Group Description:
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® 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.
Overall Number of Participants Analyzed 111 113
Measure Type: Number
Unit of Measure: percent of subjects
7.2 19.5
Time Frame Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fibrin Sealant Grifols Surgicel®
Hide Arm/Group Description 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® 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.
All-Cause Mortality
Fibrin Sealant Grifols Surgicel®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Fibrin Sealant Grifols Surgicel®
Affected / at Risk (%) Affected / at Risk (%)
Total   30/163 (18.40%)   23/162 (14.20%) 
Blood and lymphatic system disorders     
Anaemia  1/163 (0.61%)  0/162 (0.00%) 
Disseminated intravascular coagulation  0/163 (0.00%)  1/162 (0.62%) 
Febrile neutropenia  1/163 (0.61%)  1/162 (0.62%) 
Haemorrhagic anaemia  1/163 (0.61%)  0/162 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1/163 (0.61%)  2/162 (1.23%) 
Bradycardia  1/163 (0.61%)  0/162 (0.00%) 
Cardiac arrest  1/163 (0.61%)  1/162 (0.62%) 
Cardiac failure congestive  2/163 (1.23%)  0/162 (0.00%) 
Congestive cardiomyopathy  1/163 (0.61%)  0/162 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1/163 (0.61%)  0/162 (0.00%) 
Ascites  0/163 (0.00%)  1/162 (0.62%) 
Haemorrhoidal haemorrhage  0/163 (0.00%)  1/162 (0.62%) 
Ileus  2/163 (1.23%)  0/162 (0.00%) 
Intestinal perforation  1/163 (0.61%)  0/162 (0.00%) 
Localised intraabdominal fluid collection  2/163 (1.23%)  0/162 (0.00%) 
Small intestinal obstruction  1/163 (0.61%)  0/162 (0.00%) 
General disorders     
Device occlusion  1/163 (0.61%)  0/162 (0.00%) 
Extravasation  0/163 (0.00%)  1/162 (0.62%) 
Fatigue  1/163 (0.61%)  0/162 (0.00%) 
Multi-organ failure  0/163 (0.00%)  1/162 (0.62%) 
Pyrexia  1/163 (0.61%)  1/162 (0.62%) 
Hepatobiliary disorders     
Biloma  1/163 (0.61%)  0/162 (0.00%) 
Hepatic failure  2/163 (1.23%)  1/162 (0.62%) 
Hepatic necrosis  1/163 (0.61%)  0/162 (0.00%) 
Ischaemic hepatitis  1/163 (0.61%)  0/162 (0.00%) 
Portal vein thrombosis  1/163 (0.61%)  0/162 (0.00%) 
Infections and infestations     
Abdominal abscess  1/163 (0.61%)  2/162 (1.23%) 
Clostridium difficile colitis  1/163 (0.61%)  0/162 (0.00%) 
Enterovirus infection  0/163 (0.00%)  1/162 (0.62%) 
Liver abscess  2/163 (1.23%)  0/162 (0.00%) 
Pneumonia  2/163 (1.23%)  0/162 (0.00%) 
Postoperative wound infection  1/163 (0.61%)  0/162 (0.00%) 
Rhinovirus infection  0/163 (0.00%)  1/162 (0.62%) 
Sepsis  2/163 (1.23%)  1/162 (0.62%) 
Sepsis syndrome  1/163 (0.61%)  0/162 (0.00%) 
Septic shock  1/163 (0.61%)  0/162 (0.00%) 
Upper respiratory tract infection  0/163 (0.00%)  2/162 (1.23%) 
Wound infection  1/163 (0.61%)  0/162 (0.00%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence  1/163 (0.61%)  0/162 (0.00%) 
Post procedural bile leak  4/163 (2.45%)  2/162 (1.23%) 
Post procedural haemorrhage  1/163 (0.61%)  1/162 (0.62%) 
Venous injury  0/163 (0.00%)  1/162 (0.62%) 
Wound evisceration  1/163 (0.61%)  0/162 (0.00%) 
Investigations     
Electrocardiogram ST segment abnormal  1/163 (0.61%)  0/162 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  2/163 (1.23%)  1/162 (0.62%) 
Failure to thrive  1/163 (0.61%)  0/162 (0.00%) 
Gout  0/163 (0.00%)  1/162 (0.62%) 
Hyponatraemia  1/163 (0.61%)  0/162 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic neoplasm  1/163 (0.61%)  0/162 (0.00%) 
Neuroendocrine carcinoma  0/163 (0.00%)  1/162 (0.62%) 
Nervous system disorders     
Brain injury  1/163 (0.61%)  0/162 (0.00%) 
Loss of consciousness  1/163 (0.61%)  0/162 (0.00%) 
Neuralgia  0/163 (0.00%)  1/162 (0.62%) 
Syncope  1/163 (0.61%)  0/162 (0.00%) 
Transient ischaemic attack  0/163 (0.00%)  1/162 (0.62%) 
Psychiatric disorders     
Delirium  0/163 (0.00%)  1/162 (0.62%) 
Renal and urinary disorders     
Renal failure  1/163 (0.61%)  1/162 (0.62%) 
Renal failure acute  3/163 (1.84%)  0/162 (0.00%) 
Urinary retention  0/163 (0.00%)  1/162 (0.62%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  4/163 (2.45%)  1/162 (0.62%) 
Pulmonary embolism  3/163 (1.84%)  1/162 (0.62%) 
Respiratory failure  3/163 (1.84%)  1/162 (0.62%) 
Surgical and medical procedures     
Lung operation  1/163 (0.61%)  0/162 (0.00%) 
Vascular disorders     
Deep vein thrombosis  3/163 (1.84%)  1/162 (0.62%) 
Embolism  1/163 (0.61%)  0/162 (0.00%) 
Haemorrhage  0/163 (0.00%)  1/162 (0.62%) 
Hypertensive crisis  0/163 (0.00%)  1/162 (0.62%) 
Hypotension  2/163 (1.23%)  1/162 (0.62%) 
Shock  1/163 (0.61%)  0/162 (0.00%) 
Vena cava thrombosis  1/163 (0.61%)  0/162 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fibrin Sealant Grifols Surgicel®
Affected / at Risk (%) Affected / at Risk (%)
Total   131/163 (80.37%)   136/162 (83.95%) 
Blood and lymphatic system disorders     
Anaemia  21/163 (12.88%)  26/162 (16.05%) 
Cardiac disorders     
Tachycardia  14/163 (8.59%)  24/162 (14.81%) 
Gastrointestinal disorders     
Abdominal pain  10/163 (6.13%)  3/162 (1.85%) 
Constipation  20/163 (12.27%)  23/162 (14.20%) 
Nausea  34/163 (20.86%)  38/162 (23.46%) 
Vomiting  13/163 (7.98%)  17/162 (10.49%) 
General disorders     
Oedema peripheral  14/163 (8.59%)  11/162 (6.79%) 
Pyrexia  16/163 (9.82%)  19/162 (11.73%) 
Injury, poisoning and procedural complications     
Incision site pain  12/163 (7.36%)  11/162 (6.79%) 
Procedural haemorrhage  9/163 (5.52%)  4/162 (2.47%) 
Procedural pain  59/163 (36.20%)  61/162 (37.65%) 
Metabolism and nutrition disorders     
Hyperglycaemia  6/163 (3.68%)  11/162 (6.79%) 
Hypokalaemia  6/163 (3.68%)  11/162 (6.79%) 
Hypophosphataemia  8/163 (4.91%)  15/162 (9.26%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  11/163 (6.75%)  10/162 (6.17%) 
Dyspnoea  3/163 (1.84%)  11/162 (6.79%) 
Pleural effusion  11/163 (6.75%)  9/162 (5.56%) 
Skin and subcutaneous tissue disorders     
Pruritus  12/163 (7.36%)  12/162 (7.41%) 
Vascular disorders     
Hypertension  14/163 (8.59%)  12/162 (7.41%) 
Hypotension  21/163 (12.88%)  9/162 (5.56%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henry Li, PhD
Organization: Grifols Therapeutics Inc
Phone: +1 919 316 6042
EMail: henry.li@grifols.com
Layout table for additonal information
Responsible Party: Grifols Biologicals, LLC ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT01754480    
Other Study ID Numbers: IG1102
First Submitted: December 18, 2012
First Posted: December 21, 2012
Results First Submitted: December 16, 2016
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017