Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-14 @ 5:51 AM
Study NCT ID:
NCT03454633
Status:
UNKNOWN
Last Update Posted:
2018-08-06
First Post:
2018-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D057867', 'term': 'Endoleak'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomised controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2018-02-25', 'studyFirstSubmitQcDate': '2018-03-04', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '3 months within surgery.', 'description': 'In-hospital Mortality or other related death'}, {'measure': 'Re-thoracotomy', 'timeFrame': 'Through the hospitalization, an average of 4 weeks.', 'description': 'Postoperative bleeding or other conditions require re-thoracotomy'}, {'measure': 'Neurological disorder', 'timeFrame': 'Through the hospitalization, an average of 4 weeks.', 'description': 'Any neurological event occur after surgery, including transient and permanent.'}], 'secondaryOutcomes': [{'measure': 'HCA time', 'timeFrame': 'During the operation', 'description': 'the time of hypothermic circulatory arrest'}, {'measure': 'Aorta-cross clamp time', 'timeFrame': 'During the operation', 'description': 'the time of aortic-cross clamp'}, {'measure': 'CPB time', 'timeFrame': 'During the operation', 'description': 'the time of cardiopulmonary bypass'}, {'measure': 'Operation time', 'timeFrame': 'During the operation', 'description': 'the time of the entire surgery.'}, {'measure': 'ICU stay', 'timeFrame': 'Through the ICU stay, an average of 1 weeks.', 'description': 'the day of ICU treatment'}, {'measure': 'Time of mechanical ventilation', 'timeFrame': 'Through the use of ventilation, an average of 3 days.', 'description': 'the time of using respirator'}, {'measure': 'Blood transfusion', 'timeFrame': 'Through the hospitalization, an average of 4 weeks.', 'description': 'the number of blood product during the hospitalization, including red blood cell, platelet, plasma and so on.'}, {'measure': 'Dialysis', 'timeFrame': 'Through the hospitalization, an average of 4 weeks.', 'description': 'postoperative renal failure requiring dialysis'}, {'measure': 'Hospital stay', 'timeFrame': 'Through the hospitalization, an average of 4 weeks.', 'description': 'the time of hospitalization'}, {'measure': 'Postoperative aneurysm', 'timeFrame': '1 year within the surgery', 'description': 'Aortic aneurysm develope after the surgery'}, {'measure': 'Postoperative endoleak', 'timeFrame': '1 year within the surgery', 'description': 'Stent-graft endoleak occurs after the surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperthermic circulatory arrest; Surgery'], 'conditions': ['Morality', 'Hypothermic Circulatory Arrest Time', 'Aortic-cross Clamping Time', 'Cardiopulmonary Bypass Time', 'Operation Time', 'Re-Thoracotomy', 'ICU Stay', 'Mechanical Ventilation Time', 'Blood Transfusion', 'Neurological Disorder', 'Dialysis', 'Aneurysm', 'Endoleak', 'Hospital Stay']}, 'descriptionModule': {'briefSummary': 'By comparing the clinical outcome of patients underwent different hypothermic circulatory arrest (mild hypothermic versus moderate hypothermic) during aortic arch surgery, this study aims to determine the optimal hypothermic circulatory arrest strategy for aortic surgery.', 'detailedDescription': "Hypothermic circulatory arrest (HCA) is the cornerstone of aortic surgery. It provides a bloodless and still operative field. But the side effect of hypothermia also draws people's concern. With the development of surgical techniques and cardiopulmonary bypass (CPB) management, the temperature of HCA has been raised from deep hypothermia (14.1-20 degree) to moderate hypothermia (20.1-28 degree), and it has been a primary choice for many surgeons around the world. Some of surgeons still tried to push the limit and started using mild hypothermia (28.1-34 degree), and satisfactory outcome was obtained. However, the optimal temperature of HCA has not yet been determined.\n\nIn this randomized controlled study, 80 informed and consenting patients who are scheduled for total arch replacement with concomitant proximal aortic reconstruction will be randomized to mild (28.1-34 degree) or moderate (20.1-28 degree) hypothermia during circulatory arrest. Clinical outcomes of both groups will be analyzed to determine the optimal temperature for HCA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement.\n\nExclusion Criteria:\n\n1. Preoperative heart attack or coma.\n2. Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency.\n3. Pre-existing heart condition or neurological disease.\n4. Variation of aortic arch or its branch vessels.\n5. Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation.\n6. Patient with active infection.\n7. Allergy to anaesthetic or contrast agent.\n8. Pregnant or lactating female.\n9. Patient is already on other medical trial.\n10. Other medical, psychological or socioeconomics condition determined by investigator that is not eligible for the study.'}, 'identificationModule': {'nctId': 'NCT03454633', 'briefTitle': 'A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'A Comparative Study of Mild Hypothermic Circulatory Arrest Versus Moderate Hypothermic Circulatory Arrest on Aortic Surgery.', 'orgStudyIdInfo': {'id': '2017316H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild hypothermia', 'description': 'Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius', 'interventionNames': ['Procedure: the temperature of hypothermic circulatory arrest']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate hypothermia', 'description': 'Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius', 'interventionNames': ['Procedure: the temperature of hypothermic circulatory arrest']}], 'interventions': [{'name': 'the temperature of hypothermic circulatory arrest', 'type': 'PROCEDURE', 'description': 'Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.', 'armGroupLabels': ['Mild hypothermia', 'Moderate hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xiaoping Fan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong General Hosiptal'}, {'name': 'Jie He, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong General Hosiptal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaoping Fan. MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jie He.MD', 'class': 'UNKNOWN'}, {'name': 'Shihao Cai.MD', 'class': 'UNKNOWN'}, {'name': 'Wenda Gu.PhD', 'class': 'UNKNOWN'}, {'name': 'Haijiang Guo.PhD', 'class': 'UNKNOWN'}, {'name': 'Liang Hong. MD', 'class': 'UNKNOWN'}, {'name': 'Ruixing Fan.PhD', 'class': 'UNKNOWN'}, {'name': 'Jingsong Huang.PhD', 'class': 'UNKNOWN'}, {'name': 'Tucheng Sun.MD', 'class': 'UNKNOWN'}, {'name': 'Jihai Peng.MD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Xiaoping Fan. MD', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}