Platelet and Autotransfusion Device in Cardiac Surgery

NCT ID: NCT06629311

Last Updated: 2025-04-03

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-04

Study Completion Date

2026-09-08

Brief Summary

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Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Some devices, such as I-SEP's SAME®, can also be used to recover platelets, but their effectiveness has not yet been evaluated in real-life situations. The aim of this study is therefore to investigate the evolution of platelet counts following the use of an intraoperative recovery device in adult patients undergoing standard cardiac surgery

Detailed Description

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Conditions

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Platelets Autotransfusion Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Autotransfusion device

Standard cardiac surgery using I-SEP and SAME™ autotransfusion device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age
* Having undergone standard cardiac surgery (excluding redux surgery, dissection, endocarditis, circulatory assist and transplants)
* Treated with an autotransfusion device during the surgery
* Subject having expressed their consent to the study

Exclusion Criteria

* Anemia less than 7 g/dL
* Pregnant women
* Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
* Contraindication to the use of an autotransfusion device
* Impossibility of giving the subject informed information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charles TACQUARD, PHU

Role: CONTACT

+33 6 69 55 16 08

Other Identifiers

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9264

Identifier Type: -

Identifier Source: org_study_id

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