Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05487469
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2022-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012214', 'term': 'Rheumatic Heart Disease'}], 'ancestors': [{'id': 'D012213', 'term': 'Rheumatic Fever'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077596', 'term': 'Thymalfasin'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery', 'timeFrame': '5 days after surgery'}], 'secondaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30 days after randomization', 'description': 'Death from any cause of 30 days after randomization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatic Heart Disease', 'Cardiopulmonary Bypass', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': 'Rheumatic heart disease usually accompanied by weakened immune function. And the cardiopulmonary bypass further aggravating the decline of immune function. Therefore, the prevention of Postoperative immune function collapse is of great clinical value, and immunomodulatory therapy with thymosin alpha\n\n1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 will Improve the immune function and prognosis of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patients are conformed to 2004 WHO guidelines for Rheumatic fever and rheumatic heart disease;\n* Patients planning to undergo cardiac surgery were enrolled.\n* The patients' age between 18 \\~80 years old.\n* Agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Patients allergic to Thymosin α1;\n* Lactating women and pregnant women;\n* Patients with mental diseases, drug and alcohol dependence;\n* Refuse to participate in this study and refuse to sign the informed consent"}, 'identificationModule': {'nctId': 'NCT05487469', 'briefTitle': 'Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': '5A Plan IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thymosin alpha 1', 'interventionNames': ['Drug: Thymosin Alpha1']}, {'type': 'SHAM_COMPARATOR', 'label': 'Blank control', 'interventionNames': ['Other: Blank Control']}], 'interventions': [{'name': 'Thymosin Alpha1', 'type': 'DRUG', 'description': 'Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead', 'armGroupLabels': ['Thymosin alpha 1']}, {'name': 'Blank Control', 'type': 'OTHER', 'description': 'the Control group did not receive Thymosin alpha 1 or any placebo.', 'armGroupLabels': ['Blank control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '188012181613'}, {'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'DR.HONGLIU@FOXMAIL.COM', 'phone': '18801281613'}, {'name': 'Hong Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The first affiliated hospital of nanjing medical university', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'DR.HONGLIU@FOXMAIL.COM', 'phone': '18801281613'}, {'name': 'Sheng Zhao, MD', 'role': 'CONTACT', 'email': 'zhaosheng0824@163.com', 'phone': '02568303105'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator of Cardiovascular Surgery', 'investigatorFullName': 'Hong Liu', 'investigatorAffiliation': 'Nanjing Medical University'}}}}