Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-23 @ 12:51 AM
Study NCT ID:
NCT06766032
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057725', 'term': 'Operative Blood Salvage'}], 'ancestors': [{'id': 'D020858', 'term': 'Tissue and Organ Harvesting'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient', 'timeFrame': 'up to 1 week', 'description': 'The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient in the Cell-saver group or in the SAME group.'}], 'secondaryOutcomes': [{'measure': 'Postoperative platelet', 'timeFrame': '5 days', 'description': 'Postoperative platelet count between day 1 and day 5'}, {'measure': 'Perioperative and postoperative transfusions', 'timeFrame': '28 days', 'description': 'Frequency of perioperative and postoperative transfusions, number and type of blood products transfused from surgery (day 1) to 28 days after surgery'}, {'measure': 'Derivative medications', 'timeFrame': '28 days', 'description': 'Use of derivative medications (fibrinogen, prothrombin complex concentrates) from surgery (day 1) to 28 days after surgery'}, {'measure': 'Postoperative bleeding', 'timeFrame': '28 days', 'description': 'Volume of postoperative bleeding from surgery (day 1) to 28 days after surgery'}, {'measure': 'Postoperative events', 'timeFrame': '28 days', 'description': 'Frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) from surgery (day 1) to 28 days after surgery'}, {'measure': 'Durations of stays', 'timeFrame': '28 days', 'description': 'Duration of stays in the intensive care unit and in the hospital from surgery (day 1) to 28 days after surgery'}, {'measure': 'Postoperative anemia', 'timeFrame': '28 days', 'description': 'Frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents from surgery (day 1) to 28 days after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cell-saver', 'auto-transfusion', 'platelet transfusion', 'blood saving techniques'], 'conditions': ['Cardiac Surgery Under Extra Corporeal Circulation', 'Cardiac Surgery Requiring Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion. The objective is to evaluate whether platelet recovery provides better quality of hemostasis during and after surgery, improving transfusion savings, and whether it reduces postoperative complications and the length of stay in the intensive care unit and in the hospital.', 'detailedDescription': '° Primary outcome of the study : The primary outcome of the study is to compare the evolution of perioperative platelet count based on the type of blood recovery used, either SAME or Cell-Saver.\n\nThe main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient between the SAME and Cell-Saver groups.\n\n° Secondary outcomes of the study:\n\nThe secondary outcomes are to evaluate, from the preoperative period until day 28 postoperatively:\n\n* The post-operative platelet count between days 1 and 5\n* The frequency of perioperative and postoperative transfusions, including the number and type of blood products transfused\n* The use of derivative medications (fibrinogen, prothrombin complex concentrates)\n* The volume of postoperative bleeding\n* The frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic)\n* The length of stay in the intensive care unit and in the hospital\n* The frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients treated by the cardiac surgery department of Nantes University Hospital who undergo a cardiovascular procedure with cardiopulmonary bypass considered to be at high risk for bleeding; (prolonged cardiopulmonary bypass \\>2 hours, aortic arch surgery, history of redo cardiac surgery, combined surgery, multiple portocoronary bypasses). Procedures for which a perioperative blood recovery device (SAME or Cell-Saver) has been used, with the choice of the blood recovery technique at the discretion of the medical team.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled cardiac surgery under cardiopulmonary bypass with a predicted duration of more than 2 hours, or surgery of the aortic arch, redo surgery, multiple aorto-coronary bypasses (\\>2), or combined surgery (valvular and coronary).\n\nExclusion Criteria:\n\n* Pre-existing constitutional or acquired bleeding disorder (hemophilia A or B, von Willebrand disease, myelodysplastic/myeloproliferative syndrome)\n* Patients with sepsis, a malignant tumor at the surgical site, or contamination of recovered blood with biological fluids/antiseptics/distilled water/local antibiotics/hemostatic agents.\n* Organ transplantation and planned circulatory support in the preoperative period\n* Uni-bi-ventricular artificial heart\n* Reoperation in a patient already included in the study\n* Patient refusing blood transfusion\n* Pregnant women\n* Legally Protected adults'}, 'identificationModule': {'nctId': 'NCT06766032', 'acronym': 'SAME-CELL', 'briefTitle': 'Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver for Red Blood Cell Reinfusion and SAME for Red Blood Cell and Platelet Reinfusion', 'orgStudyIdInfo': {'id': 'AR_2024_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cell-Saver group', 'description': 'Patients for whom the Cell-saver device is used during cardiac surgery.', 'interventionNames': ['Device: CELL-Saver']}, {'label': 'SAME group', 'description': 'Patients for whom the SAME device is used during cardiac surgery.', 'interventionNames': ['Device: SAME']}], 'interventions': [{'name': 'CELL-Saver', 'type': 'DEVICE', 'description': 'The Cell-saver device allows for red blood cell reinfusion during cardiac surgery.', 'armGroupLabels': ['Cell-Saver group']}, {'name': 'SAME', 'type': 'DEVICE', 'description': 'The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery.', 'armGroupLabels': ['SAME group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': "Mickaël Vourc'h, MD-PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes HU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}