Platelet Function After Cardiac Surgery.

NCT ID: NCT06405516

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Platelet Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients undergoing cardiac surgery using the conventional cell saver device

Group Type ACTIVE_COMPARATOR

Autologous blood cell salvage with in-house device

Intervention Type DEVICE

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.

Patients undergoing cardiac surgery using the cell saver device

Group Type EXPERIMENTAL

Autologous cell salvage with i-Sep SAME device

Intervention Type DEVICE

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.

Interventions

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Autologous blood cell salvage with in-house device

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.

Intervention Type DEVICE

Autologous cell salvage with i-Sep SAME device

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Elective high risk cardiac surgery with cardiopulmonary bypass usage
* Cardiopulmonary bypass time \> 120 minutes
* Written informed consent

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabor Erdoes, MD

Role: STUDY_CHAIR

University of Bern

Locations

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Department of Anesthesiology and Pain Medicine

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Fabio Barattiero, MD

Role: CONTACT

004131632111

Gabor Erdoes, MD

Role: CONTACT

004131632111

Facility Contacts

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Gabor Erdoes, MD PhD

Role: primary

0041316322726

Other Identifiers

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BASEC 2023-D0074

Identifier Type: -

Identifier Source: org_study_id

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