Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-23 @ 3:15 PM
Study NCT ID:
NCT02584868
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2013-07-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
Sponsor:
Organization:
Raw JSON
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{'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2013-07-03', 'resultsFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-16', 'studyFirstPostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calculated Blood Loss at 3rd Post Operative Day (POD)', 'timeFrame': '72H post surgery'}], 'secondaryOutcomes': [{'measure': 'Intraoperative Blood Loss', 'timeFrame': 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admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)'}, {'measure': 'PTT', 'timeFrame': 'End of surgery, an average of 200 minutes'}, {'measure': 'APTT', 'timeFrame': 'End of surgery, an average of 200 minutes'}, {'measure': 'INR', 'timeFrame': 'End of surgery, an average of 200 minutes'}, {'measure': 'Fibrinogen', 'timeFrame': 'End of surgery, an average of 200 minutes'}, {'measure': 'Clotting Time in Seconds', 'timeFrame': 'End of surgery, an average of 200 minutes', 'description': 'Clotting time on EXTEM ROTEM®'}, {'measure': 'Maximal Cloth Firmness', 'timeFrame': 'End of surgery, an average of 200 minutes', 'description': 'Maximal cloth firmness on EXTEM ROTEM®'}, {'measure': 'Creatinine', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'CRP', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'PTT', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'APTT', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'INR', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'Fibrinogen', 'timeFrame': 'Post-operative Day 1'}, {'measure': 'Creatinine', 'timeFrame': 'Post-operative Day 2'}, {'measure': 'CRP', 'timeFrame': 'Post-operative Day 2'}, {'measure': 'PTT', 'timeFrame': 'Post-operative Day 2'}, {'measure': 'APTT', 'timeFrame': 'Post-operative Day 2'}, {'measure': 'INR', 'timeFrame': 'Post-operative Day 2'}, {'measure': 'Fibrinogen', 'timeFrame': 'Post-operative Day 2'}, {'measure': 'Creatinine', 'timeFrame': 'Post-operative Day 3'}, {'measure': 'CRP', 'timeFrame': 'Post-operative Day 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery', 'Cardiopulmonary Bypass']}, 'referencesModule': {'references': [{'pmid': '33966019', 'type': 'DERIVED', 'citation': 'Willems A, De Groote F, Schmartz D, Fils JF, Van der Linden P. Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial? Eur J Anaesthesiol. 2021 Sep 1;38(9):923-931. doi: 10.1097/EJA.0000000000001526.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 28 days to 3 years old\n* Planned cardiac surgery with cardiopulmonary by-pass\n* signed informed consent\n\nExclusion Criteria:\n\n* Moribund patients (ASA 5)\n* Jehovah Witnesses\n* Pre-operative coagulation disorders\n* Pre-operative renal insufficiency\n* Pre-operative hepatic disorders\n* Intra-cranial hemorrhage\n* hypernatremia'}, 'identificationModule': {'nctId': 'NCT02584868', 'acronym': 'COLCHIRCARD', 'briefTitle': 'Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid', 'organization': {'class': 'OTHER', 'fullName': "Queen Fabiola Children's University Hospital"}, 'orgStudyIdInfo': {'id': '2011-006034-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volulyte', 'description': 'Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)', 'interventionNames': ['Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voluven', 'description': 'Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)', 'interventionNames': ['Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride']}], 'interventions': [{'name': 'Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution', 'type': 'DRUG', 'otherNames': ['Volulyte'], 'description': 'Peri-operative fluid replacement therapy (max 40ml/kg/day)', 'armGroupLabels': ['Volulyte']}, {'name': 'Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride', 'type': 'DRUG', 'otherNames': ['Voluven'], 'description': 'Peri-operative fluid replacement therapy (max 40ml/kg/day)', 'armGroupLabels': ['Voluven']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Universitaire Des Enfants Reine Fabiola', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Philippe Van der Linden, MDPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUDERF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen Fabiola Children's University Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}