Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-04-23 @ 2:31 AM
Study NCT ID:
NCT05030259
Status:
RECRUITING
Last Update Posted:
2021-09-01
First Post:
2021-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Research About the ACS After Femoropopliteal Arterial Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071938', 'term': 'Fasciotomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of amputation', 'timeFrame': 'up to 6 months'}, {'measure': 'fasciotomy performed or not', 'timeFrame': 'up to 2 weeks'}], 'secondaryOutcomes': [{'measure': 'the rate of primary skin closure', 'timeFrame': 'up to 1 months'}, {'measure': 'hospital lengths of stay', 'timeFrame': 'up to 6 months'}, {'measure': 'injury mechanism of patients', 'timeFrame': 'up to 1 week'}, {'measure': 'the costs of hospitalization', 'timeFrame': 'up to 2 months'}, {'measure': 'tourniquet used or not', 'timeFrame': 'up to 1 week'}, {'measure': 'the time of using tourniquet', 'timeFrame': 'up to 1 week'}, {'measure': 'the time to surgical intervention', 'timeFrame': 'up to 1 month'}, {'measure': 'extremity Abbreviated Injury Scale of patients', 'timeFrame': 'up to 1 week', 'description': 'minimum is 1, maximum is 6, higher scores mean a worse outcome'}, {'measure': 'Injury Severity Score of patients', 'timeFrame': 'up to 1 week', 'description': 'minimum is 0, maximum is 75, higher scores mean a worse outcome'}, {'measure': 'concomitant injury of patients', 'timeFrame': 'up to 1 week'}, {'measure': 'time of skin closure', 'timeFrame': 'up to 1 month'}, {'measure': 'admission hemoglobin of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'admission pH of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'admission lactate of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'postoperative lactate of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'admission International Normalized Ratio of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'postoperative International Normalized Ratio of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'admission CK of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'postoperative CK of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'admission LDH of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'postoperative LDH of patients', 'timeFrame': 'up to 1 month'}, {'measure': 'Number of Participants with Lower Extremity Arteriosclerosis Obliterans', 'timeFrame': 'up to 1 week'}, {'measure': 'vascular repair technique of patients', 'timeFrame': 'up to 1 week'}, {'measure': 'Number of Participants with sepsis', 'timeFrame': 'up to 1 month'}, {'measure': 'Ischemia time of patients', 'timeFrame': 'up to 1 week'}, {'measure': 'Postoperative knee function of patients', 'timeFrame': 'up to 6 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACS', 'femoropopliteal arterial injuries', 'fasciotomy'], 'conditions': ['Acute Compartment Syndrome']}, 'descriptionModule': {'briefSummary': 'Crural Compartment syndrome is a well-known sequela after femoropopliteal arterial injuries in the lower extremity, particularly when there has been a long period of ischemia,need for ligation of a major vein, or when there is severe associated soft tissue.There is conteoversy in the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with femoropopliteal arterial injuries in our hospital who will be treated with vascular repair.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with femoropopliteal arterial injuries\n* patients older than 18 years\n\nExclusion Criteria:\n\n* Patients who did not survive to discharge\n* Patients with primary amputation\n* patients younger than 18 years'}, 'identificationModule': {'nctId': 'NCT05030259', 'briefTitle': 'The Research About the ACS After Femoropopliteal Arterial Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Third Hospital'}, 'officialTitle': 'ACS After Femoropopliteal Arterial Injuries', 'orgStudyIdInfo': {'id': 'HZY005ACS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with fasciotomy', 'interventionNames': ['Procedure: fasciotomy']}, {'label': 'patients without fasciotomy'}], 'interventions': [{'name': 'fasciotomy', 'type': 'PROCEDURE', 'description': 'To perform fasciotomy', 'armGroupLabels': ['patients with fasciotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sun Changsheng', 'role': 'CONTACT', 'email': '15176139310@163.com', 'phone': '15176139310'}], 'facility': 'the Third Hospital of Hebei Medical Univesity', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'centralContacts': [{'name': 'Guo Jialiang, Doctor', 'role': 'CONTACT', 'email': 'drjlguo86@gmail.com', 'phone': '18203222090'}], 'overallOfficials': [{'name': 'Hou Zhiyong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Medical University Third Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2 years after the experiment was conducted', 'ipdSharing': 'YES', 'description': 'acute compartment syndrome', 'accessCriteria': 'all authors focusing on ACS research'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}