Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery

NCT04588350 | Completed DMC

• 1 other identifier: ETC2017-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous or autotransfusion method (which is done with the patient's own blood). Although homologous transfusions can save lives, it can cause significant adverse events. Since then, multiple solutions have been developed to avoid exposing patients to these risks. It is in this context that was born the "Patient Blood Management" (PBM). Thus, the strategy in this PBM has been defined as "the appropriate use of blood and blood components, with the aim of minimizing the use of allogeneic transfusions". In this context, particular interest has been given to autologous transfusion or autotransfusion or cell salvage, the general purpose is to reduce (or even stop) the use of allogeneic products and to reduce the risks associated with the ABO compatibility system, as well as all the adverse effects associated with allogeneic plasma and platelet transfusions. Most autotransfusers available on the market operate by centrifugation. Autotransfusion is already a solution in Patient Blood Management and its efficiency and safety have already been optimized. However, there is still a need to improve the quality of the treated blood with an easier-to-use device that could improve the quality of the blood concentrate. Indeed, with the current devices, it may happen that the use of allogeneic transfusions, plasma and platelets transfusions, is necessary in addition to autologous red blood cells thus reducing the interest of autotransfusion. It is in this context that i-SEP has developed a new autotransfusion device based on a filtration method. Unlike competing devices, the i-SEP device allows the concentration of not only red blood cells (as competitive devices) but also platelets. In this study, the i-SEP device is used in typical clinical applications of autotransfusion: cardiovascular and orthopedic surgeries, where there is a risk of hemorrhage and/or blood loss for example ≥ 500mL in cardiac surgery and ≥ 300mL in orthopedic surgery. The study includes a screening phase (≤ 21Days), surgery phase when the i-SEP device is used (Day 0), a post-surgery phase (Day 1 - Day 6), a first follow-up visit (Day 7 ± 3) and a second follow-up visit (Day 30 ± 7).

Conditions

Hemorrhage; Blood Loss; Surgical Blood Loss

Keywords

Autotransfusion; Cell salvage; Patient blood management

Outcome Measures

Primary Outcomes (2)

• Safety of the device in terms of elimination of contaminants such as heparin and hemolysis markers (free hemoglobin)

  Proportion of patients with heparin washout ≥ 90% and with free hemoglobin washout ≥ 75% on the concentrated blood from the i-SEP device

  Day 0

• Performance of the device in terms of exceeding red blood cell recovery and hematocrit / hemoglobin thresholds

  Proportion of patients with mean Red Blood Cells (RBCs) recovery ≥ 80% and with mean output Hematocrit ≥ 40% or hemoglobin concentration ≥ 13.3g/dL. Mean recovery is calculated with quantification in the pre-treatment blood (after pre-filtration through the blood collection reservoir) and quantification in the concentrated blood, mean output is calculated on the concentrated blood.

  Day 0

Secondary Outcomes (15)

• Incidence of adverse events

  Up to 1 month follow-up

• Incidence of homologous transfusion

  Up to 1 month follow-up

• Incidence of re-intervention for bleeding

  Up to 1 month follow-up

• Contaminants concentration such as heparin and hemolysis markers (free hemoglobin) in the concentrated blood

  Day 0

• Evolution of the patient's complete blood count

  Up to Day 2

Other Outcomes (1)

• User satisfaction questionnaire

  Through study completion, an average of 1 year

Study Arms (1)

i-SEP autotransfusion system

EXPERIMENTAL

Use of i-SEP autotransfusion system during the surgery

Device: i-SEP autotransfusion system

Interventions

i-SEP autotransfusion system DEVICE

Intraoperative recovery and washing of the processed blood by i-SEP autotransfusion system in surgeries where a bleeding is expected

Also known as: same TM, MT0003, i-SEP ATS

i-SEP autotransfusion system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is the patient able and willing to give informed consent before participating in the study?
• Is the patient aged ≥ 18 years?
• Does the patient have a social protection system?
• Does the patient weigh ≥ 59kg (for the sole purpose of blood assessment related to the clinical study)?
• Is the patient indicated for a cardiac surgery with the implementation of a Cardio Pulmonary Bypass (CPB)?
• Does the patient have a preoperative hemoglobin ≥ 13g / L for a man and ≥ 12g / L for a woman?
• Does the patient have a preoperative platelets count ≥ 150000 / μL?
• \- Does the patient have anticoagulated blood losses ≥ 500mL (without considering priming volume in the first cycle)?

You may not qualify if:

• Is the patient indicated for a surgery because of a suspected or confirmed cancer?
• Does the patient have any systemic or local infection in the area of intervention, suspected or proven?
• Does the patient have any pathology of hemostasis (Hemophilia, ...) or bleeding disorder confirmed, or strongly suspected on the examination of the patient in consultation (high score on the formalized questionnaire: HEMSTOP)?
• Is the patient's life expectancy of less than 2 months?
• Does the patient have any psychiatric condition that could, in the opinion of the investigator, prevent him / her from participating in this study?
• Does the patient have any objections to transfusion (homologous)?
• Is the patient participating in or has participated in another clinical study in the last 30 days at the day of screening and has received (or is receiving) treatments that could have an impact on the effectiveness of the autotransfusion?
• Does the investigator consider that the patient (or the surgical conditions) is not appropriate to be included in this clinical study?
• Does the patient have a TIH - Heparin-Induced Thrombocytopenia - suspected or confirmed and therefore cannot receive heparin?
• Is the patient pregnant or a lactating woman?
• Is the patient a woman of childbearing age who is not on effective contraceptive treatment?
• Is the patient due to have combined surgeries?
• Has the patient been admitted for an emergency surgery?
• Does the patient have an endocarditis?
• Has the patient been admitted for a redux surgery?

Sponsors & Collaborators

• i-SEP: lead

Study Sites (5)

CHU de Bordeaux - GH Pellegrin

Bordeaux, France

Location

CHU de Nantes

Nantes, France

Location

Ap-Hp - Hegp

Paris, France

Location

CHU de Bordeaux - GH Sud

Pessac, France

Location

CHU de Rennes

Rennes, France

Location

Related Publications (1)

• 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.

  PMID: 37294939 DERIVED

MeSH Terms

Conditions

Hemorrhage; Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Francis Gadrat, MD

  i-SEP

  STUDY CHAIR

• Nicolas Nesseler, MD

  CHU de Rennes, Rennes, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm study in cardiac surgery

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 19, 2020
• Study Start: September 28, 2020
• Primary Completion: May 14, 2021
• Study Completion: September 20, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)