Use of Fibrin Sealant Patch for Vein Anastomosis During D... | NCT06124209

Studies
Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial

NCT06124209

Sponsor

Medical University of Warsaw

Status

Unknown status

Last Update Posted

Feb 28, 2024Actual

Enrollment

170Estimated

Phase

Phase 4

Conditions

Liver Transplant; Complications

Interventions

TachoSil

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2023Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Nov 3, 2023

First Submission Date that Met QC Criteria

Nov 3, 2023

First Posted Date

Nov 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paweł Rykowski, MD, Medical University of WarsawPrincipal Investigator

Lead Sponsor

Medical University of WarsawOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.

The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.

Detailed Description

Studies have shown that materials containing fibrin shorten the time to hemostasis in the case of planned liver resection, but did not show a significant effect on the occurrence of postoperative bleeding. The aim of the study is to supplement knowledge about hemostatic matrices in liver transplantation, which will be used for the inferior vena cava anastomosis.

The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tachosil® used in Vena Cava Inferior anastomosis	Experimental	Tachosil® used in Vena Cava Inferior anastomosis.	Drug: TachoSil
Control	No Intervention	Standard haemostatic treatment in HPB surgery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TachoSil	Drug	TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.	Tachosil® used in Vena Cava Inferior anastomosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Significant postoperative bleeding	occurrence of significant postoperative bleeding within 10 days after surgery, defined as the occurrence of one of the following: occurrence of hematoma larger than 100ml transfusion of packed red blood cells after surgery performing relaparotomy due to bleeding	10 days

Secondary Outcomes

Measure	Description	Time Frame
Postoperative complication	Occurance of complication assesed in Clavien-Dindo scale	10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 18
elective liver transplantation
informed consent to participate in the study

Exclusion Criteria:

-decision to use packing during liver transplantation (bail out strategy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paweł Rykowski, MD	Contact	+48 22 599 2359		pawel.rykowski@wum.edu.pl

Overall Officials

Name	Affiliation	Role
Paweł Rykowski, MD	Medical University of Warsaw	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of General Transplant and Liver Surgery	Recruiting	Warsaw	Mazovian Voivodeship	02-097	Poland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonimized IPD would be shared after personal contact, after PI approval

Types

Study Protocol
Clinical Study Report (CSR)
Analytic Code

Time Frame

5 years after study finish

Access Criteria

scintific puropse only

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C518955	TachoSil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided