Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04912193
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2021-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antithrombin III and Post-liver Transplantation Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000990', 'term': 'Antithrombin III'}], 'ancestors': [{'id': 'D058833', 'term': 'Antithrombin Proteins'}, {'id': 'D015843', 'term': 'Serpins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000510', 'term': 'Alpha-Globulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D019774', 'term': 'Blood Coagulation Factor Inhibitors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2395}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-30', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-05-30', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute kidney injury', 'timeFrame': 'postoperative 7 day', 'description': 'serum creatinine \\>0.3 mg/dL within POD 2 or increase by \\>1.5 times within POD 7 according to the criteria set by the Kidney Disease: Improving Global Outcomes (KDIGO) classification'}], 'secondaryOutcomes': [{'measure': 'chronic kidney disease', 'timeFrame': 'postoperative 3 months', 'description': 'glomerular filtration rate less than 60 mL∙min-1∙1.73m-2 on two consecutive occasions at least 3 months apart'}, {'measure': 'early allograft dysfucion', 'timeFrame': 'postoperative 7 day', 'description': 'at least one of the following: total bilirubin ≥10 mg/dL on postoperative day (POD) 7, prothrombin time (INR) ≥1.6 on POD 7, and alanine or aspartate aminotransferases \\>2000 IU/L within POD 7'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute kidney injury', 'antithrombins', 'liver transplantation'], 'conditions': ['Liver Transplantation and Antithrombin']}, 'referencesModule': {'references': [{'pmid': '26676884', 'type': 'BACKGROUND', 'citation': 'Levy JH, Sniecinski RM, Welsby IJ, Levi M. Antithrombin: anti-inflammatory properties and clinical applications. Thromb Haemost. 2016 Apr;115(4):712-28. doi: 10.1160/TH15-08-0687. Epub 2015 Dec 17.'}, {'pmid': '29466798', 'type': 'BACKGROUND', 'citation': 'Wu R, Kong Y, Yin J, Liang R, Lu Z, Wang N, Zhao Q, Zhou Y, Yan C, Wang F, Liang M. Antithrombin Ⅲ is a Novel Predictor for Contrast Induced Nephropathy After Coronary Angiography. Kidney Blood Press Res. 2018;43(1):170-180. doi: 10.1159/000487499. Epub 2018 Feb 16.'}, {'pmid': '28219627', 'type': 'BACKGROUND', 'citation': 'Lu Z, Cheng D, Yin J, Wu R, Zhang G, Zhao Q, Wang N, Wang F, Liang M. Antithrombin III Protects Against Contrast-Induced Nephropathy. EBioMedicine. 2017 Mar;17:101-107. doi: 10.1016/j.ebiom.2017.02.009. Epub 2017 Feb 12.'}, {'pmid': '26108065', 'type': 'RESULT', 'citation': 'Wang F, Zhang G, Lu Z, Geurts AM, Usa K, Jacob HJ, Cowley AW, Wang N, Liang M. Antithrombin III/SerpinC1 insufficiency exacerbates renal ischemia/reperfusion injury. Kidney Int. 2015 Oct;88(4):796-803. doi: 10.1038/ki.2015.176. Epub 2015 Jun 24.'}, {'pmid': '28767184', 'type': 'RESULT', 'citation': 'Yin J, Wang F, Kong Y, Wu R, Zhang G, Wang N, Wang L, Lu Z, Liang M. Antithrombin III prevents progression of chronic kidney disease following experimental ischaemic-reperfusion injury. J Cell Mol Med. 2017 Dec;21(12):3506-3514. doi: 10.1111/jcmm.13261. Epub 2017 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'The reno-protective effect of Antithrombin III (ATIII) has been well-studied in various animal studies; however, little is known about the effect of ATIII on kidney function in patients undergoing liver transplantation (LT). This study aimed to determine the association between preoperative ATIII level and postoperative acute kidney injury (AKI) after LT (post-LT AKI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018 in Asan Medical Center.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018\n\nExclusion Criteria:\n\n* patients who underwent re-transplantation\n* patients who were previously diagnosed with end-stage renal disease or Chronic kidney disease\n* patients who were being treated with continuous renal replacement therapy\n* preoperative or postoperative Antithrombin III levels were not available'}, 'identificationModule': {'nctId': 'NCT04912193', 'briefTitle': 'Antithrombin III and Post-liver Transplantation Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Low Preoperative Antithrombin III Level is Associated With Postoperative Acute Kidney Injury After Liver Transplantation', 'orgStudyIdInfo': {'id': '2019-1699'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'antithrombin III < 50 %', 'description': 'preoperative antithrombin III levels \\<50%', 'interventionNames': ['Drug: Antithrombin III']}, {'label': 'Antithrombin III ≥ 50 %', 'description': 'preoperative antithrombin III levels ≥ 50 %'}], 'interventions': [{'name': 'Antithrombin III', 'type': 'DRUG', 'description': 'In liver transplant recipients with baseline antithrombin III levels lower than 50%, exogenous Antithrombin III was administrated during the anhepatic phase of the liver transplant surgery.', 'armGroupLabels': ['antithrombin III < 50 %']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05507', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Fellow', 'investigatorFullName': 'Kyoung-Sun Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}