Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-01-17 @ 2:06 AM
Study NCT ID:
NCT06627218
Status:
RECRUITING
Last Update Posted:
2024-10-04
First Post:
2024-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005164', 'term': 'Factor IX'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-hospital mortality', 'timeFrame': '14 days', 'description': 'in-hospital mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trauma', 'Major Bleeding'], 'conditions': ['Traumatic Bleeding']}, 'descriptionModule': {'briefSummary': 'Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.', 'detailedDescription': 'Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge.\n\nThe use of prothrombin complex concentrate (PCC) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis.\n\nCertainly, the utility of PCC was a residual question in the management of traumatic coagulopathy. Uncertainty remains on the indication of use.The 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM, provided that fibrinogen levels are normal. The recommendation Grade is 2C.Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old or \\< 80 years old\n2. Trauma treated in resuscitation unit/emergency room patient\n3. Hospital admission within 24h after injury\n4. Assessment of blood consumption (ABC) score ≥2 points.\n\nExclusion Criteria:\n\n1. PCC was used before admission\n2. Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.)\n3. Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction)\n4. Patients with traumatic cardiac arrest in hospital\n5. Women during breastfeeding, pregnancy or pregnancy\n6. Patients with hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction'}, 'identificationModule': {'nctId': 'NCT06627218', 'briefTitle': 'Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following Trauma：A Multicenter Retrospective Study', 'orgStudyIdInfo': {'id': '2021-0580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adhere to Recommendations for PCC Management', 'description': 'Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma', 'interventionNames': ['Drug: Prothrombin Complex Concentrate']}, {'type': 'NO_INTERVENTION', 'label': 'Liberal PCC Management', 'description': 'Liberal PCC Management in Major Bleeding Following Trauma'}], 'interventions': [{'name': 'Prothrombin Complex Concentrate', 'type': 'DRUG', 'otherNames': ['test group'], 'description': 'Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma', 'armGroupLabels': ['Adhere to Recommendations for PCC Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yongan xu, doctor', 'role': 'CONTACT', 'email': 'xuyongan2000@zju.edu.cn', 'phone': '13757164833'}], 'facility': 'Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University,', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'yongan xu, doctor', 'role': 'CONTACT', 'email': 'xuyongan2000@163.com', 'phone': '13757164833'}, {'name': 'yangbo kang, master', 'role': 'CONTACT', 'email': '1179619719@qq.com', 'phone': '19858878803'}], 'overallOfficials': [{'name': 'yongan xu, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Emergency medicine，Second Affiliated Hospital of Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}