Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT06657534
Status:
RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SISIPUSH: Evaluation of Hemolysis and Iatrogenic Anemia Using the Push-pull Method to Obtain Blood from Pediatric Patients with Central Venous Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of hemoglobin', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'trend of hemoglobin (from the first blood draw after randomization to the last blood draw during the same hospitalization), which is defined as the sum of the negative differences of hemoglobin determinations (grams per deciliter) between two consecutive blood draws'}], 'secondaryOutcomes': [{'measure': 'Hemolysis', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'analysis of hemolysis parameters on all blood samples (distribution of serum potassium and lactate dehydrogenase between the two study populations)'}, {'measure': 'Anemia onset', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'proportion of patients diagnosed with anemia (hemoglobin \\<7 g/dl) during hospitalization'}, {'measure': 'Need for erytrocyte transfusion', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'number of patients undergoing a packed red blood cell transfusion during hospitalization, expressed as proportion of patients compared to total number of patients, in number of transfusions per total number of blood samples and in number of transfusions per day of hospitalization since inclusion'}, {'measure': 'Hemolytic samples', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'proportion of blood samples reported by the clinical laboratory as hemolytic'}, {'measure': 'Failed blood samples', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'proportion of blood samples that were not analyzable and reason for this (hemolysis or other)'}, {'measure': 'Bacteremia onset', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'proportion of patients with bacteremia (positive blood culture) during the course of the study'}, {'measure': 'Catheter dysfunction', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'proportion of patients in whom the central venous catheter had to be removed early due to dysfunction or infection'}, {'measure': 'Operator ease of use', 'timeFrame': 'from randomization to discharge from the hospital or removal of the central venous catheter', 'description': 'assessment of satisfaction (0-5) and complexity (0-5) of the procedure by the healthcare personnel performing the blood sampling'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['push-pull technique'], 'conditions': ['Pediatrics', 'Central Venous Catheter']}, 'descriptionModule': {'briefSummary': 'Anemia is frequently observed during hospitalizations, both in adults and children. In addition to the fact that anemia can be caused by an acute or chronic condition, blood samples taken during the hospital stay contribute to additional blood loss (so-called iatrogenic anemia).\n\nFor children, the relative amount of blood taken at each blood collection is greater than in adults. It is therefore expected that in children, due to the lower circulating blood volume, the relative impact of repeated blood sampling is greater and interventions such as sparing the number of blood samples or blood volume can have a relevant impact on the onset of anemia, the need for iron supplements or blood transfusions and the general clinical recovery.\n\nFor children, only limited data are available on the development of iatrogenic anemia during hospital stay. In a study of children in an intensive care unit, a decrease in hemoglobin of 0.7 g/dl can already be seen with an average stay of 4.5 days (and an average number of blood samples of 2.9) (François et al. Ped Crit Car Med, 2022). The average blood volume lost to blood samples during the stay is 3.9 ml/kg, which already corresponds to 5% of the total blood volume. Interventions to decrease the frequency of blood sampling or to perform the same analyses on a smaller blood volume (e.g. adapted, smaller blood tubes for children) are therefore useful in preventing the development of anemia during a hospital stay, especially in children.\n\nAlternative methods have been described to save on blood volume when performing blood sampling, especially if these are performed via central venous catheters (surgically or non-surgically placed). To obtain a suitable sample via such catheters, the usual technique is to obtain 5 to 10 ml of blood and discard the volume (so-called "waste blood") before the sample for laboratory analysis is obtained (typically only 1-2 ml). A recently published technique is the so-called push-pull method (described by McBride et al, J Infus Nurs 2018), in which blood sampling can be performed without waste blood.\n\nThe push-pull technique has been studied in children, but mainly in oncological and intensive care units. Paired analyses have verified that the technique provides a reliable sample for most blood analyses, including blood count, electrolytes, liver and kidney function parameters, CRP, but also coagulation factors and therapeutic drug monitoring. The occurrence of complications, of which the development of catheter-related bacteremia is of particular importance, is not described. A beneficial effect on anemia onset has not yet been described, usually due to low patient numbers per study (23-35 patients).\n\nIn SISIPUSH, we compare the push-pull technique with the standard-of-care in hospitalised children who undergo blood sampling via a central venous catheter for diagnostic reasons (in the context of routine care). By means of a 1:1 randomization, eligible patients who gave informed consent are assigned to one of the two methods for the remainder of the hospitalization. From the moment of randomization until discharge from the hospital, data will be collected from the medical file that are collected routinely (number of blood samples, hemoglobin values, number of blood transfusions, markers of hemolysis, age and gender, reason for hospitalization, type of catheter) and compared between the two groups. In parallel, nurses score the easy of use and satisfaction with the procedure at each blood sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalized patient at the Specialist Pediatric Department of Ghent University Hospital\n* age 0-18 years\n* presence of a central venous catheter for diagnostic or therapeutic reasons of the type surgically placed (Hickman, port-a-cath) or non-surgically placed (vena jugularis interna, subclavia, femoralis,...)\n* patent catheter with possibility of infusion of fluids and collection of blood on at least one of the lumens\n* clinical and/or radiographic confirmation of correct central position of the catheter tip\n* at least one blood collection per week hospitalization expected or already planned\n\nExclusion Criteria:\n\n* presence of a bloodstream or catheter related infection before or at the time of randomization'}, 'identificationModule': {'nctId': 'NCT06657534', 'acronym': 'SISIPUSH', 'briefTitle': 'SISIPUSH: Evaluation of Hemolysis and Iatrogenic Anemia Using the Push-pull Method to Obtain Blood from Pediatric Patients with Central Venous Catheters', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'SISIPUSH: Evaluation of Hemolysis and Iatrogenic Anemia Using the Push-pull Method to Obtain Blood from Pediatric Patients with Central Venous Catheters', 'orgStudyIdInfo': {'id': 'ONZ-2024-0215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Push-pull technique', 'interventionNames': ['Procedure: Push-pull technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard of care blood sampling method with waste blood', 'interventionNames': ['Procedure: SOC (Standard of care)']}], 'interventions': [{'name': 'Push-pull technique', 'type': 'PROCEDURE', 'description': 'push-pull technique as described by McBride et al, J Infus Nurs 2018', 'armGroupLabels': ['Intervention']}, {'name': 'SOC (Standard of care)', 'type': 'PROCEDURE', 'description': 'Standard of care method to obtain blood with waste blood', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Levi Hoste, MD, PhD', 'role': 'CONTACT', 'email': 'levi.hoste@uzgent.be', 'phone': '+32 9 332 35 40'}], 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Levi Hoste, MD, PhD', 'role': 'CONTACT', 'email': 'levi.hoste@uzgent.be', 'phone': '+32 9 332 35 40'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'January 2026', 'ipdSharing': 'YES', 'description': 'peer-reviewed publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}