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OpenTrials
Completed

NCT Number: NCT01324349

Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.

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Key information

Conditions

Liver Disease Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Major Inclusion Criteria:

  • Scheduled for non-emergent, hepatic surgery
  • Presence of an appropriate target bleeding site (TBS) as defined by the protocol

Major Exclusion Criteria:

  • Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar
  • In subjects with documented history of cirrhosis, subject has uncorrected platelet count <60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
  • Subject has severe coagulopathy defined as INR > 2.0
  • Subject has Total Bilirubin >2.5mg/dL
  • Subject has an active local infection at the Target Bleeding Site
  • Study procedure involves a liver transplant recipient

Treatment and study plan

Veriset Hemostatic Patch

Device

Topical hemostat

Fibrin Sealant (TachoSil®)

Device

Topical hemostat

Primary outcomes

  1. Median Time to Achieve Hemostasis Following Application of Study Treatment.

    Time frame: Intra-operative (day 1)

    Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.

Secondary outcomes

  1. Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application

    Time frame: Intra-operative (day 1)

    Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.

  2. Number of Subjects With Treatment-emergent Adverse Events

    Time frame: Up to 30 days post surgery.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2011
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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