Bleeding during liver resection and the efficacy of 2 types of hemostatic patches on this, thus all diagnosis' that require liver resection. MedDRA version: 17.1 Level: LLT Classification code 10060663 Term: Surgical hemostasis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Tachosil
Product Name: Tachosil
Pharmaceutical Form: Sealant matrix
INN or Proposed INN: THROMBIN
CAS Number: 9002-04-4
Other descriptive name: human thrombin
Concentration unit: IU intern
Sponsors
Rigshospitalet, department of surgical Gastroenterology, C-Tx
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Electice patients scheduled for liver resection, who have signed the written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Lack of need for a hemostatic patch/ hemostasis during the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the medical device Hemopatch, has a higher efficacy in obtaining hemostasis during liver resection than Tachosil;Secondary Objective: To assess whether the medical device Hemopatch, has a lower rate of post-operative complications than Tachosil within 30 days.;Primary end point(s): Immediate failure-rate of Hemostatic patch. Failure is defined as: • Inability to stop non-arterial bleeding from the area covered by the agent/patch - Blood oozing from the rims of the patch or hematoma formation between the patch and the surface. • The patch slips completely or partly from the covered area. All 4 sides of the patch should adhere tightly to the surface. • The patch perforates or disintegrates during manipulation. ;Timepoint(s) of evaluation of this end point: Each patch is assessed after application, thus per-operative evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Perioperative bleeding. • Postoperative bile leakage • Length of admission/in-hospital stay. • Intraabdominal absces formation. ;Timepoint(s) of evaluation of this end point: 30 day follow up after surgery. | — |
Countries
Denmark
Contacts
Public ContactHemostasisproject(Hemopatch)
Rigshospitalet, department of surgical Gastroenterology, C-Tx
Outcome results
None listed