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Liver TransplantPLFLTSNCT06357455

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

A study testing Cell Salvage Autotransfusion: SAME™ device and Cell Salvage Autotransfusion: Autolog™ device in people with Liver Transplant and Hemorrhage, Surgical, run by Eduardo Schiffer at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Liver Transplant, Hemorrhage, Surgical
What is being tested?
Cell Salvage Autotransfusion: SAME™ device and Cell Salvage Autotransfusion: Autolog™ device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSwitzerland
Study dates
1 Jun 2024to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All adult patients undergoing liver transplantation surgery

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Eduardo Schiffer, MD contact

+41 22 372 3060

eduardo.schiffer@hcuge.ch

Tony Mouawad, MD contact

+41 79 553 2117

tony.mouawad@hcuge.ch

Switzerland1 site

  • Geneva University Hospitals

    Geneva, 1211

    Eduardo Schiffer, MD, eduardo.schiffer@hcuge.ch

    Tony Mouawad, MD

Other trials in Switzerland

About this study

Official title: 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.

Read the 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).
Being tested
Cell Salvage Autotransfusion: SAME™ device, Cell Salvage Autotransfusion: Autolog™ device
Medical subject headings
Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cell Salvage Autotransfusion: SAME™ deviceDevice

    • 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.

  • Cell Salvage Autotransfusion: Autolog™ deviceDevice

    • 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.

Study groups in NCT06357455
Study groupRoleWhat they receive
SAME™ Device groupExperimentalSAME™ Autotransfusion Device that is being tested for recovery of platelets along with RBCs
Receives: Device: Cell Salvage Autotransfusion: SAME™ device
Autolog™ Device groupActive comparatorAutolog™ standard autotransfusion device currently used at our institution
Receives: Device: Cell Salvage Autotransfusion: Autolog™ device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Platelet number

    Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient.

    Measured: Day 1

Secondary outcomes (14)

  1. Platelet function

    Platelets function will be assessed by multiple electrode aggregometry (Multiplate® analyzer, Roche Diagnostics, Mannheim, Germany).

    Measured: Day 1

  2. Platelet function

    Platelets function will be measured by platelet activation markers (P-selectin)

    Measured: Day 1

  3. Platelet function

    Platelets function will be measured by platelet activation markers (GPIb)

    Measured: Day 1

  4. Platelet function

    Platelets function will be measured by platelet activation markers (GPIIb)

    Measured: Day 1

  5. Platelet function

    Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using ExTest.

    Measured: Day 1

  6. Platelet function

    Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using FibTest assays.

    Measured: Day 1

  7. Blood plasma albumin level

    measured by spectrophotometry

    Measured: Day 1

  8. Blood hemoglobin level

    measured by spectrophotometry

    Measured: Day 1

  9. Blood lactate level

    measured by spectrophotometry

    Measured: Day 1

  10. Free hemoglobin level

    measured by spectrophotometry

    Measured: Day 1

  11. Anti-Xa activity

    measured by Anti-Xa assay

    Measured: Day 1

  12. Number of allogeneic blood products used

    Number of allogeneic blood products used (red blood cell, fresh frozen plasma, platelet concentrates) until ICU discharge

    Measured: Day 1

  13. Number of coagulation concentrates used

    Number of coagulation concentrates used (prothrombin complex concentrate, fibrinogen concentrate) until ICU discharge

    Measured: Day 1

  14. Amount of autologous blood at the end of the liver transplantation

    Amount of autologous blood at the end of the liver transplantation

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357455
Sponsor's protocol ID
Platelet CellSaver Liver trnsp
Acronym
PLFLTS
Status last verified
Apr 2024
First submitted
26 Mar 2024
Last updated
10 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mansour A, Beurton A, Godier A, Rozec B, Zlotnik D, Nedelec F, Gaussem P, Fiore M, Boissier E, Nesseler N, Ouattara A. Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study). Anesthesiology. 2023 Sep 1;139(3):287-297. doi: 10.1097/ALN.0000000000004642.

    PubMed 37294939

  • Mansour A, Decouture B, Roussel M, Lefevre C, Skreko L, Picard V, Ouattara A, Bachelot-Loza C, Gaussem P, Nesseler N, Gouin-Thibault I. Combined Platelet and Erythrocyte Salvage: Evaluation of a New Filtration-based Autotransfusion Device. Anesthesiology. 2021 Aug 1;135(2):246-257. doi: 10.1097/ALN.0000000000003820.

    PubMed 33984126

  • Klein AA, Bailey CR, Charlton AJ, Evans E, Guckian-Fisher M, McCrossan R, Nimmo AF, Payne S, Shreeve K, Smith J, Torella F. Association of Anaesthetists guidelines: cell salvage for peri-operative blood conservation 2018. Anaesthesia. 2018 Sep;73(9):1141-1150. doi: 10.1111/anae.14331. Epub 2018 Jul 10.

    PubMed 29989144

  • Sikorski RA, Rizkalla NA, Yang WW, Frank SM. Autologous blood salvage in the era of patient blood management. Vox Sang. 2017 Aug;112(6):499-510. doi: 10.1111/vox.12527. Epub 2017 Jun 5.

    PubMed 28580663

  • Schreiber K, Decouture B, Lafragette A, Chollet S, Bruneau M, Nicollet M, Wittmann C, Gadrat F, Mansour A, Forest-Villegas P, Gauthier O, Touzot-Jourde G. A novel autotransfusion device saving erythrocytes and platelets used in a 72 h survival swine model of surgically induced controlled blood loss. PLoS One. 2022 Mar 24;17(3):e0260855. doi: 10.1371/journal.pone.0260855. eCollection 2022.

    PubMed 35324911

Questions about this trial

What is this clinical trial studying?

A study testing Cell Salvage Autotransfusion: SAME™ device and Cell Salvage Autotransfusion: Autolog™ device in people with Liver Transplant and Hemorrhage, Surgical, run by Eduardo Schiffer at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eduardo Schiffer, MD (+41 22 372 3060, eduardo.schiffer@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Platelet number (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357455, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

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