The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
225
Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Direct manual compression of target bleeding site with gauze/laparotomy pads.
407
Florence, Alabama, United States
125
Palo Alto, California, United States
119
San Diego, California, United States
149
Jacksonville, Florida, United States
148
Jacksonville, Florida, United States
137
Tampa, Florida, United States
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.
Time frame: From start of treatment until 4 minutes after treatment start
Time to Hemostasis (TTH)
Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start. In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated. All calculations were performed using SAS PROC LIFETEST
Time frame: From start of treatment until 10 minutes after treatment start
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 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
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.
Time frame: From start of treatment until 10 minutes after treatment start
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140
Atlanta, Georgia, United States
114
Iowa City, Iowa, United States
110
Lexington, Kentucky, United States
146
Baton Rouge, Louisiana, United States
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