Platelet DysfunctionPLFICSNCT06405516
Platelet Function After Cardiac Surgery.
A study testing Autologous blood cell salvage with in-house device and Autologous cell salvage with i-Sep SAME device in people with Platelet Dysfunction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Intraoperative cell salvage is commonly used in cardiac surgery 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 older
- Conditions the study is for
- Platelet Dysfunction
- What is being tested?
- Autologous blood cell salvage with in-house device and Autologous cell salvage with i-Sep SAME 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
- 12 Jun 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Elective high risk cardiac surgery with cardiopulmonary bypass usage
- Cardiopulmonary bypass time > 120 minutes
- Written informed consent
Who cannot join
- Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
- Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine
Bern, 3010
Gabor Erdoes, MD PhD, 0041316322726, gabor.erdoes@insel.ch
About this study
Official title: Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.
Intraoperative cell salvage is commonly used in cardiac surgery 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 situation after cardiac surgery.
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 retransfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the cardiac surgery population.
The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.
- Conditions
- Platelet Dysfunction
- Being tested
- Autologous blood cell salvage with in-house device, Autologous cell salvage with i-Sep SAME device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous blood cell salvage with in-house deviceDevice
In addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood.
Autologous cell salvage with i-Sep SAME deviceDevice
In addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiac surgery using the conventional cell saver device | Active comparator | Not described Receives: Device: Autologous blood cell salvage with in-house device |
| Patients undergoing cardiac surgery using the cell saver device | Experimental | Not described Receives: Device: Autologous cell salvage with i-Sep SAME device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet number
Platelet number as measured by flow cytometry after processing and retransfusion of the salvaged blood to the patient.
Measured: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Secondary outcomes (6)
Platelet function measured by multiple electrode aggregometry
Platelet function, as measured by point-of-care test
Measured: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured by platelet activation markers (P-selectin)
Platelet function, as measured by point-of-care test
Measured: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured by platelet activation markers (GPIb and GPIIb)
Platelet function, as measured by point-of-care test
Measured: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured with viscoelastic point-of-care test (Clotpro)
Platelet function, measured by point-of-care test using ExTest und FibTest assays with viscoelastic point-of-care test device
Measured: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured with viscoelastic point-of-care test (ROTEM)
Platelet function, measured by point-of-care test using ExTEM und FibTEM assays with viscoelastic point-of-care test device
Measured: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Number of allogeneic blood products transfused
Number of allogeneic blood products used (red blood cell, fresh frozen)
Measured: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start12 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Gabor Erdoes, MD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405516
- Sponsor's protocol ID
- BASEC 2023-D0074
- Acronym
- PLFICS
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.
- ClinicalTrials.gov ID
- NCT06405516
- Acronym / sponsor ID
- PLFICS / BASEC 2023-D0074
- Conditions
- Platelet Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University of Zurich
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intraoperative cell salvage is commonly used in cardiac surgery 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 situation after cardiac surgery.
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 retransfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the cardiac surgery population.
The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac surgery using the conventional cell saver device | Active comparator | Device: Autologous blood cell salvage with in-house device |
| Patients undergoing cardiac surgery using the cell saver device | Experimental | Device: Autologous cell salvage with i-Sep SAME device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Elective high risk cardiac surgery with cardiopulmonary bypass usage
- Cardiopulmonary bypass time > 120 minutes
- Written informed consent
Key exclusion criteria (2 listed)
- Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
- Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous blood cell salvage with in-house deviceIn addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood. | Device | Patients undergoing cardiac surgery using the conventional cell saver device |
| Autologous cell salvage with i-Sep SAME deviceIn addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood. | Device | Patients undergoing cardiac surgery using the cell saver device |
Primary outcome
Platelet number
Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet number as measured by flow cytometry after processing and retransfusion of the salvaged blood to the patient.
6 secondary outcomes
Platelet function measured by multiple electrode aggregometry
Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured by platelet activation markers (P-selectin)
Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured by platelet activation markers (GPIb and GPIIb)
Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured with viscoelastic point-of-care test (Clotpro)
Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured with viscoelastic point-of-care test (ROTEM)
Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Number of allogeneic blood products transfused
Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabor Erdoes, MD study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous blood cell salvage with in-house device and Autologous cell salvage with i-Sep SAME device in people with Platelet Dysfunction, run by Insel Gruppe AG, University Hospital Bern 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Barattiero, MD (004131632111, fabio.barattiero@insel.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: Perioperative period (begins on the day of surgery and ends on the day after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.