Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT03780894
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005340', 'term': 'Fibrinogen'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial.\n\nThe experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)', 'timeFrame': 'Basal (at the crash site)', 'description': 'TEG6s(R) parameters that define TIC'}, {'measure': 'TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)', 'timeFrame': 'Basal (at the hospital arrival)', 'description': 'TEG6s(R) parameters that define TIC'}, {'measure': 'All-cause mortality', 'timeFrame': '1 hour post hospital admission', 'description': 'Mortality for any cause'}, {'measure': 'All-cause mortality', 'timeFrame': '6 hours post hospital admission', 'description': 'Mortality for any cause'}, {'measure': 'All-cause mortality', 'timeFrame': '24 hours post hospital admission', 'description': 'Mortality for any cause'}, {'measure': 'Accountability', 'timeFrame': '30 days', 'description': 'Red bood cells concentrate accountability'}, {'measure': 'Temperature storage conditions of the red blood cells concentrate', 'timeFrame': '24 hours', 'description': 'Red bood cells concentrate out of temperature range for storage'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '48 hours post hospital admission', 'description': 'Mortality for any cause'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days post hospital admission', 'description': 'Mortality for any cause'}, {'measure': 'Adverse Events', 'timeFrame': '30 days post hospital admission (or previously at hospital discharge)', 'description': 'Treatment emergent adverse events'}, {'measure': 'Thromboembolism events', 'timeFrame': '30 days', 'description': 'Thromboembolism events'}, {'measure': 'Crystalloid fluid requirements', 'timeFrame': '1 hour (from the crash site to the hospital admission)', 'description': 'Volume of crystalloids required'}, {'measure': 'Crystalloid fluid requirements', 'timeFrame': '30 days post hospital admission (or previously at hospital discharge)', 'description': 'Volume of crystalloids required'}, {'measure': 'Transfusion requirements', 'timeFrame': '24 hours (or previously at discharge of the emergency room)', 'description': 'Transfusion requirements of RBC, platelets and plasma'}, {'measure': 'Transfusion requirements', 'timeFrame': '30 days post hospital admission (or previously at hospital discharge)', 'description': 'Transfusion requirements of RBC, platelets and plasma'}, {'measure': 'Water balance', 'timeFrame': '24 hours of admission at the ICU', 'description': 'Water balance at the Intensive Care Unit (ICU)'}, {'measure': 'Water balance', 'timeFrame': '72 hours of admission at the ICU', 'description': 'Water balance at the Intensive Care Unit (ICU)'}, {'measure': 'Ventilator-free days', 'timeFrame': '30 days', 'description': 'Ventilator-free days at the ICU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polytrauma', 'Red blood cells transfusion', 'Acute traumatic hemorrhage'], 'conditions': ['Polytrauma', 'Traumatic Hemorrhage']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bancsang.net', 'label': 'Blood and Tissue Bank of Catalonia'}, {'url': 'http://icsgirona.cat', 'label': 'HOspital Universitari Dr. Trueta (Girona, Spain)'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.', 'detailedDescription': 'A pilot, non-randomized, open-label study of two intervention arms and controlled with the standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma will enter the study with the main objective of evaluating the feasibility and the efficacy of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen concentrate and tranexamic acid (experimental arm) compared to the standard treatment based on crystalloids administration and tranexamic acid (control arm). The secondary objectives are to evaluate the safety and clinical evolution of the patients. Prior to the administration of the treatment, 2 blood samples will be extracted in both groups in order to compare the coagulation status and to be able to perform the pre-transfusion tests. On arrival at the hospital, another sample will be taken to compare changes in coagulation after the administration of the experimental or standard treatment and also between both groups. The assessment of the coagulation status will be made using the values provided by the viscoelastic test (TEG6s). The experimental and standard treatment will be administered endovenously. After treatment, patients will be evaluated up to 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years AND\n* Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND\n* Evidence of bleeding or a high bleeding suspicion according to physician judgment OR\n* Predicted to need transfusion according to TICCS score ≥10\n\nExclusion Criteria:\n\n* Moribund patient with devastating injuries and expected to die within 1-hour OR\n* Known objection to blood components transfusion OR\n* Known acquired or congenital coagulopathies not related to the actual trauma OR\n* Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR\n* Known Pregnancy OR\n* Severe isolated traumatic brain injury OR\n* Hemorrhage not related to the actual trauma'}, 'identificationModule': {'nctId': 'NCT03780894', 'acronym': 'PRETIC', 'briefTitle': 'Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.', 'organization': {'class': 'OTHER', 'fullName': 'Banc de Sang i Teixits'}, 'officialTitle': 'Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.', 'orgStudyIdInfo': {'id': 'PRETIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental treatment', 'description': 'The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.', 'interventionNames': ['Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]', 'Biological: Red blood cells concentrate', 'Drug: Tranexamic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.', 'interventionNames': ['Drug: Tranexamic Acid']}], 'interventions': [{'name': 'Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]', 'type': 'DRUG', 'description': 'Administration of 2 mg of FC together with RBC and TXA', 'armGroupLabels': ['Experimental treatment']}, {'name': 'Red blood cells concentrate', 'type': 'BIOLOGICAL', 'description': 'Administration of 2 red blood cells concentrates together with FC and TXA', 'armGroupLabels': ['Experimental treatment']}, {'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': 'Administration of 1g of TXA together with FC and RBC', 'armGroupLabels': ['Experimental treatment', 'Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Banc de Sang i Teixits', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}