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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192022
• Other study ID #: TC-2402-040-SP
• Secondary ID: U1111-1130-9121
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2010
• Last updated: October 22, 2015
• Start date: August 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Biological:
• TachoSil®
Intraoperative application as secondary hemostatic treatment

Device:
• Surgicel® Original
Intraoperative application as secondary hemostatic treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No