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

Takeda

Status and phase: Completed; Phase 3

Conditions: Hemorrhage

Treatments: Biological: TachoSil®; Device: Surgicel® Original

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192022

TC-2402-040-SP

U1111-1130-9121 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 253 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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253 participants in 2 patient groups

TachoSil®

Active Comparator group

Description:

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.

Treatment:

Biological: TachoSil®

Surgicel® Original

Active Comparator group

Description:

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.

Treatment:

Device: Surgicel® Original