Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 12:34 AM
Study NCT ID:
NCT02750150
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fibrinogen concentration (clauss)', 'timeFrame': '45 minutes after the admission on day 1 after trauma'}], 'secondaryOutcomes': [{'measure': 'time frame of transfusion of 4 plasma', 'timeFrame': 'time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after admission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Trauma', 'Coagulopathy']}, 'descriptionModule': {'briefSummary': 'Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency\n* Trauma patient admitted in participating trauma care centers\n* Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.\n* Inclusion performed within the first 6 hours after trauma.\n\nExclusion Criteria:\n\n* Patient taking anticoagulants\n* Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)\n* Minor Patient\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT02750150', 'acronym': 'TrauCC', 'briefTitle': 'Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients', 'orgStudyIdInfo': {'id': '2011_61'}, 'secondaryIdInfos': [{'id': '2012-A00075-38', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Freezed-dried plasma', 'description': 'transfusion of 4 units of freezed dried plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)', 'interventionNames': ['Drug: Freezed-dried plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fresh-frozen plasma', 'description': 'transfusion of 4 units of fresh frozen plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma)', 'interventionNames': ['Drug: Fresh-frozen plasma']}], 'interventions': [{'name': 'Freezed-dried plasma', 'type': 'DRUG', 'description': 'early transfusion of 4 units of freezed dried plasma', 'armGroupLabels': ['Freezed-dried plasma']}, {'name': 'Fresh-frozen plasma', 'type': 'DRUG', 'armGroupLabels': ['Fresh-frozen plasma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Emergency unit, Salengro hospital,', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Sophie Susen, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}