Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT06349551
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter', 'timeFrame': '5 minutes (T5)', 'description': 'Activation of coagulation in the clearing fluid will be assessed by a composite criterion defined by:\n\n* the presence of a macroscopic clot (binary YES or NO criterion) or\n* fibrinogen consumption (binary YES or NO criterion). Fibrinogen consumption will be classified as YES when its decrease, compared with the reference value measured at T0, is greater than the known technical variability of the assay method'}], 'secondaryOutcomes': [{'measure': 'Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter', 'timeFrame': '5 minutes (T5)', 'description': 'Prothrombin time will be assayed at T0, T3 and T5'}, {'measure': 'Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter', 'timeFrame': '5 minutes (T5)', 'description': 'Factor II will be assayed at T0, T3 and T5'}, {'measure': 'Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter', 'timeFrame': '5 minutes (T5)', 'description': 'Factor V will be assayed at T0, T3 and T5'}, {'measure': 'Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter', 'timeFrame': '5 minutes (T5)', 'description': 'Fibrin monomers will be assayed at T0, T3 and T5'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intensive Care Units', 'Arterial Lines']}, 'descriptionModule': {'briefSummary': 'After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented.', 'detailedDescription': "In the intensive care unit, blood sampling is mainly performed through an arterial catheter (radial or femoral artery). In addition to continuous arterial pressure monitoring, this provides an easy access to arterial blood without the need for venipuncture.\n\nIt is standard practice to first clear the arterial sampling line before drawing blood for biological tests, to prevent the blood sample from being diluted by the arterial catheter's perfusion solution. This clearing fluid (i.e., a mixture of saline solution and blood) is usually discarded. It has been reported that the clearing fluid volume alone represents 24 to 30% of the total blood volume required for blood sampling.\n\nDevices for reinjecting this clearing fluid are already on the market. The advantages of these devices include blood saving, reduced risk of blood exposure, reduced biological waste and lower infection rates associated with catheter handling. The main drawback of these devices is their cost and the need for frequent replacement. Moreover, their impact on the decrease of blood transfusion remains unclear.\n\nFurthermore, there are too few published data on the potential coagulation of clearing fluid reinjected into the patient nor the maximum time it can be safely reinjected.\n\nThe aim of this study is to assess the activation of coagulation over time in the clearing fluid during arterial catheter blood sampling"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patient with arterial catheter (radial or femoral).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18 years old\n* Admitted to the ICU\n* With a radial or femoral arterial catheter\n* Requiring blood sampling\n\nExclusion Criteria:\n\n* Presence of a non-standard extension line: any tubing other than an arterial line intended for this purpose.\n* Constitutional or acquired hemorrhagic disease,\n* Major biological thrombophilia (anti-phospholipid syndrome, homozygous mutation of factor II or V, protein C, S or antithrombin deficiency),\n* Thromboembolic event in progress or \\< 6 months,\n* Bacteremia within the last 48 hours,\n* Previous study participation,\n* Pregnant or breast-feeding patient\n* Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment\n* Patient with no health insurance\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT06349551', 'acronym': 'SECU-BIO2', 'briefTitle': 'Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling.', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Clot Formation and Coagulation Factors Consumption Over Time in the Clearing Fluid After Arterial Catheter Blood Sampling in Critically Ill Adult Patients. Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'RC23_0586'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patients of intensive care unit', 'type': 'BIOLOGICAL', 'description': 'Patients of intensive care unit having an arterial catheter undergoing arterial blood sampling'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire-atlantique', 'country': 'France', 'facility': 'Nantes university hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44606', 'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'Hospital center', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}