Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery (PLFLTS)

April 4, 2024 updated by: Eduardo Schiffer

Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery: A Randomized Controlled Bi-Center Equivalence Trial

Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation status after these types of surgeries, especially liver transplantation.

There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population.

The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

- Study design: Randomized controlled bi-center trial

  • Primary objective: to compare platelet number and function after processing and re-transfusion of the salvaged blood to the patient by using different cell saver devices.
  • Secondary (main) objectives: to compare a) the coagulation profile and b) the usage of blood products (frequency of administration of labile and stable blood products).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All adult patients undergoing liver transplantation surgery

Exclusion Criteria:

  • Age < 18 years old
  • Active liver malignancy
  • Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
  • Inability to understand and sign the informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAME™ Device group
SAME™ Autotransfusion Device that is being tested for recovery of platelets along with RBCs
Device: Cell Salvage Autotransfusion: SAME™ device
  • Intervention studied: processing of salvaged blood using the SAME™ autotransfusion device
  • Population studied: 20 patients planned to undergo high-risk liver transplantation.
  • "Treatment" group.

All perioperative measures will be performed according to international, national and in-house standards.
Active Comparator: Autolog™ Device group
Autolog™ standard autotransfusion device currently used at our institution
Device: Cell Salvage Autotransfusion: Autolog™ device
  • Intervention studied: processing of salvaged blood using the Autolog™ (Medtronic) autotransfusion device (in-house standard device).
  • Population studied: 20 patients planned to undergo high-risk liver transplantation.
  • "Control" group

All perioperative measures will be performed according to international, national and in-house standards.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Platelet number
Time Frame: Day 1
Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Platelet function
Time Frame: Day 1
Platelets function will be assessed by multiple electrode aggregometry (Multiplate® analyzer, Roche Diagnostics, Mannheim, Germany).
Day 1
Platelet function
Time Frame: Day 1
Platelets function will be measured by platelet activation markers (P-selectin)
Day 1
Platelet function
Time Frame: Day 1
Platelets function will be measured by platelet activation markers (GPIb)
Day 1
Platelet function
Time Frame: Day 1
Platelets function will be measured by platelet activation markers (GPIIb)
Day 1
Platelet function
Time Frame: Day 1
Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using ExTest.
Day 1
Platelet function
Time Frame: Day 1
Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using FibTest assays.
Day 1
Blood plasma albumin level
Time Frame: Day 1
measured by spectrophotometry
Day 1
Blood hemoglobin level
Time Frame: Day 1
measured by spectrophotometry
Day 1
Blood lactate level
Time Frame: Day 1
measured by spectrophotometry
Day 1
Free hemoglobin level
Time Frame: Day 1
measured by spectrophotometry
Day 1
Anti-Xa activity
Time Frame: Day 1
measured by Anti-Xa assay
Day 1
Number of allogeneic blood products used
Time Frame: Day 1
Number of allogeneic blood products used (red blood cell, fresh frozen plasma, platelet concentrates) until ICU discharge
Day 1
Number of coagulation concentrates used
Time Frame: Day 1
Number of coagulation concentrates used (prothrombin complex concentrate, fibrinogen concentrate) until ICU discharge
Day 1
Amount of autologous blood at the end of the liver transplantation
Time Frame: Day 1
Amount of autologous blood at the end of the liver transplantation
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eduardo Schiffer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eduardo Schiffer, MD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Platelet CellSaver Liver trnsp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplant

Clinical Trials on Cell Salvage Autotransfusion: SAME™ device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings