The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
Dosage form: spray application; dosage frequency: single application
Dosage form: surgical gauze swab; dosage frequency: single application
Unnamed facility
Berlin, Germany
Unnamed facility
Essen, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Heidelberg, Germany
Unnamed facility
Jena, Germany
Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures: * No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success) * Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required * Reapplication of FS VH S/D 500 s-apr after 4 minutes * Intraoperative rebleeding after the first 4 minutes of the observation period
Time frame: 4 minutes post start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Time frame: 6 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
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Unnamed facility
Leipzig, Germany
Unnamed facility
Tübingen, Germany
Time frame: 8 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Time frame: 10 minutes after start of treatment application
Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.
Time frame: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding
Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration
Time frame: Postoperative until discharged from surgical ward
Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.
Time frame: Intra- and postoperative until discharged from surgical ward
Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
Time frame: Within 48 hours after surgery