Platelets in Liver Regeneration

NCT02113059 | Unknown

• 1 other identifier: PS-AS-TG-CB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The most relevant factor predicting morbidity and mortality after liver resections is the ability of the remnant liver to regenerate. The investigators recently demonstrated that serotonin and thrombospondin-1, two growth factors abundantly stored in platelets, seem to play a critical role in liver regeneration of patients after liver resection. The investigators now aim to gain more precise insight concerning the relevance of platelets and platelet derived growth factors in liver regeneration in humans. The investigators will focus on specific alpha-granula release as a key regulator of postoperative LR. Using peri- and intraoperative blood and tissue samples, platelet adhesion, granula release and induction of gene expression known to be involved in liver regeneration form experimental studies will be analyzed. This study should allow the investigators to verify observations from preclinical models and evaluate their relevance in the human setting. Furthermore, this might enable the investigators to identify new therapeutic targets.

Conditions

Liver Regeneration

Keywords

Liver regeneration; liver dysfunction; platelets; plasma; serum; platelet activation; morbidity; mortality; Growth factors; Postoperative clinical outcome

Outcome Measures

Primary Outcomes (1)

• Validation of the role of platelets in the process of early liver regeneration in humans

  Preclinical studies have identified multiple platelet associated candidate molecules in the highly regulated process of liver regeneration. Using a complex peri and intraoperative sampling schedule, we will try to validate the relevance of these molecules in the human setting.

  2 years

Secondary Outcomes (2)

• Postoperative liver dysfunction

  2 years

• Postoperative morbidity

  2 years

Study Arms (1)

Liver resection

Patients undergoing a hemihepatectomy.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

80 patients undergoing elective hemihepatectomy.

You may qualify if:

• patients undergoing elective hemihepatectomy

You may not qualify if:

• peroperative portal vein thrombosis
• age \> 85

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Rudolfstiftung

Vienna, 1030, Austria

RECRUITING

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, platelet and tissue preparation

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Patrick Starlinger, MD, PhD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

• Alice Assinger, PhD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Starlinger, MD, PhD

CONTACT

0043 40400 5621; patrick.starlinger@meduniwien.ac.at

Thomas Gruenberger, MD

CONTACT

0043 40400 5621; thomas.gruenberger@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 6, 2014
• First Posted: April 14, 2014
• Study Start: November 1, 2012
• Primary Completion: April 1, 2017
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

AU (2)