N/A
N=50
Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01324349 ↗Enrolled (actual)
50
Serious AEs
36.7%
Results posted
Sep 2012
Primary outcome: Primary: Median Time to Achieve Hemostasis Following Application of Study Treatment. — 1; 3 Minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Veriset Hemostatic Patch (Device); Fibrin Sealant (TachoSil®) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Achieve Hemostasis Following Application of Study Treatment. |
1; 3 | <0.0001 sig |
| SECONDARY Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application |
30; 12 | 0.0339 sig |
| SECONDARY Number of Subjects With Treatment-emergent Adverse Events |
23; 14 | 0.5029 |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01324349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.