TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery

Study Overview
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Brief Summary
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The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.

Official Title
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A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery

Conditions
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Hemorrhage

Intervention / Treatment
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* Biological: TachoSil®
* Device: Surgicel® Original


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation Need for additional supportive hemostatic treatment Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes Exclusion Criteria: Indication for emergency surgery Known coagulopathy (as judged relevant by the investigator) Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin) Patient unwilling to receive blood products Known current alcohol or drug abuse Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential Dry surgical field of the targeted application area Occurrence of any serious surgical complication Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding Application of topical hemostatic material on the liver resection wound Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TachoSil®<br>TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. | Biological: TachoSil®<br>* Intraoperative application as secondary hemostatic treatment<br>|
| Active Comparator: Surgicel® Original<br>Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. | Device: Surgicel® Original<br>* Intraoperative application as secondary hemostatic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes | 3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped. | within 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes | 3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped. | within 5 minutes | 
| Time to Intraoperative Hemostasis at Target Bleeding Site | The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver resection, Liver transplantation, Liver surgery, Secondary hemostasis