Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 12:12 AM
Study NCT ID:
NCT01287806
Status:
UNKNOWN
Last Update Posted:
2011-02-01
First Post:
2011-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ulinastatin in Inhalation Lung Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C028665', 'term': 'urinastatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-31', 'studyFirstSubmitDate': '2011-01-24', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'until death or discharge from hospital, data reviewed every 3 months'}], 'secondaryOutcomes': [{'measure': 'length of mechanical ventilation', 'timeFrame': 'from admission to 90 days'}, {'measure': 'length of ICU stay', 'timeFrame': 'until death or discharge from hospital, data reviewed every 3 months'}, {'measure': 'length of hospital stays', 'timeFrame': 'until death or discharge from hospital, data reviewed every 3 months'}, {'measure': 'blood inflammatory mediator', 'timeFrame': '0days,5days and 10days'}, {'measure': 'Bronchoscopy morphological evaluation', 'timeFrame': '0days,5days and 10days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ulinastatin', 'inhalation injury'], 'conditions': ['Inhalation Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe inhalation lung injury\n* Within 48hours after inhalation injury\n* Age 18 to 70 years old\n* Burned area not more than 70% TBSA\n* Signed the informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Allergy for ulinastatin\n* Received an investigational drug or device within 90 days prior to entering study'}, 'identificationModule': {'nctId': 'NCT01287806', 'briefTitle': 'Ulinastatin in Inhalation Lung Injury', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury', 'orgStudyIdInfo': {'id': 'Uilis-china'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'blank control group', 'interventionNames': ['Drug: blank group']}, {'type': 'EXPERIMENTAL', 'label': 'ulinastatin group', 'description': 'ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine', 'interventionNames': ['Drug: ulinastatin']}], 'interventions': [{'name': 'ulinastatin', 'type': 'DRUG', 'otherNames': ['brand name: noan'], 'description': 'Resolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days', 'armGroupLabels': ['ulinastatin group']}, {'name': 'blank group', 'type': 'DRUG', 'description': 'standard treatment', 'armGroupLabels': ['blank control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijin', 'state': 'Beijin', 'country': 'China', 'contacts': [{'name': 'Sheng zhiyong, MD', 'role': 'CONTACT', 'phone': '86-13910008199'}, {'name': 'Jia chiyu, MD', 'role': 'CONTACT', 'email': 'JCY304@yahoo.com.cn'}, {'name': 'Jia chiyu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '304 hospital of PLA', 'geoPoint': {'lat': 35.93305, 'lon': 111.40836}}], 'centralContacts': [{'name': 'Sheng zhiyong, MD', 'role': 'CONTACT', 'phone': '86-13910008199'}, {'name': 'Jia chiyu, MD', 'role': 'CONTACT', 'email': 'JCY304@yahoo.com.cn'}], 'overallOfficials': [{'name': 'sheng zhiyong, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Hospitals affiliated to the China PLA General Hospital'}, {'name': 'Jia chiyu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospitals affiliated to the China PLA General Hospital'}, {'name': 'Xia zhaofan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}, {'name': 'Pang yizhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southwest Hospital, China'}, {'name': 'Chen tunhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Jinan PLA Military Region'}, {'name': 'Zhu jinmin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Beijing PLA Military Region'}, {'name': 'Liu yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Lanzhou PLA Military Region'}, {'name': 'Cui xiaolin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Liaonin People's Armed Police Corps Hospital"}, {'name': 'Sheng guanyu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '187 Central Hospital of the Chinese PLA'}, {'name': 'Lu qinjun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '251 Central Hospital of the Chinese PLA'}, {'name': 'Shi shengfu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '322 Central Hospital of the Chinese PLA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Changhai Hospital', 'class': 'OTHER'}, {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, {'name': 'General Hospital of Beijing PLA Military Region', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Sheng Zhiyong', 'oldOrganization': "General Hospital of the People's Liberation Army"}}}}