Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT01545635
Status:
TERMINATED
Last Update Posted:
2016-03-23
First Post:
2012-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005340', 'term': 'Fibrinogen'}, {'id': 'D005164', 'term': 'Factor IX'}], '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': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'The Interim analysis (100 patients) revealed a possible harm to patients randomised to the fresh frozen plasma (FFP) treatment arm.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multiple Organ Failure (MOF)', 'timeFrame': 'Variable until 24h on ICU at the end of the IMP-administration', 'description': 'Difference in the MOF as assessed by the Sequential Organ Failure Assessment score (SOFA) between treatment groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major trauma', 'Injury Severity Score', 'ISS > 15', 'clinical signs', 'risk of blood loss', 'coagulopathy', 'rotational thrombelastometry', 'ROTEM'], 'conditions': ['Major Trauma']}, 'referencesModule': {'references': [{'pmid': '28457980', 'type': 'DERIVED', 'citation': 'Innerhofer P, Fries D, Mittermayr M, Innerhofer N, von Langen D, Hell T, Gruber G, Schmid S, Friesenecker B, Lorenz IH, Strohle M, Rastner V, Trubsbach S, Raab H, Treml B, Wally D, Treichl B, Mayr A, Kranewitter C, Oswald E. Reversal of trauma-induced coagulopathy using first-line coagulation factor concentrates or fresh frozen plasma (RETIC): a single-centre, parallel-group, open-label, randomised trial. Lancet Haematol. 2017 Jun;4(6):e258-e271. doi: 10.1016/S2352-3026(17)30077-7. Epub 2017 Apr 28.'}]}, 'descriptionModule': {'briefSummary': "Severe traumatized patients (ISS \\> 15) admitted to emergency department (ED) University Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient meets the inclusion criteria (T1) and is recruited for the study, a first study related blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive fresh frozen plasma (FFP),respectively.\n\nTreatment failure will be registered if bleeding persists and ROTEM parameters do not improve after two times dosages of study drug. In these cases haemostatic rescue therapy will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be administered to patients randomized to receive FFP and FFP will be administered to patients of the CFC group.\n\nIn cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy will be documented and a ROTEM will be performed thereafter.\n\nAt admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related blood samples are drawn (40mL each).\n\nThe indications for transfusion of red blood cells or platelets, administration of antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement are similar for both groups and treatment is performed according to clinical routine.\n\nBesides coagulation management during ED treatment until 24h on ICU, patient's care is not influenced by the study and follows clinical routine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female subjects =/\\> 18 years and =/\\< 80 years\n2. Major trauma (ISS \\> 15)\n3. Clinical signs of ongoing bleeding or patients who are at risk for significant haemorrhage assessed and judged by the ED team in charge of patient\n4. Presence of coagulopathy defined by ROTEM assays as follows,\n\n * Patients with concomitant decreased fibrinogen polymerisation (ROTEM® FibTEM A10 of \\< 7 mm after 10 min)\n * Patients with concomitant decreased coagulation factor levels (ROTEM® ExTEM CT of \\> 90 sec)\n\nExclusion Criteria:\n\n1. Lethal injury\n2. CPR on the scene,\n3. Isolated brain injury, burn injury\n4. Avalanche injury\n5. Administration of FFP or coagulation factor concentrates before ED admission\n6. Delayed (\\> 6hours after trauma) admittance to ED\n7. Known use of oral anticoagulants, or platelet aggregation inhibitors within 5 days before injury\n8. Known history of severe allergic reaction to plasma products\n9. Known history of congenital hemostasis disturbance, IgA or Protein C deficiency\n10. Patients with a history of thromboembolic events or heparin induced thrombocytopenia (HIT) type 2 within the last year\n11. Patients with a body weight \\< 45kg and \\> 150kg\n12. Patients that are known to be pregnant\n13. Jehova's Witness\n14. Known participation in another clinical trial\n15. Patient with known refusal of a participation in this clinical trial"}, 'identificationModule': {'nctId': 'NCT01545635', 'briefTitle': 'RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma', 'orgStudyIdInfo': {'id': 'RETIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coagulation factor concentrates', 'interventionNames': ['Drug: Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fresh Frozen Plasma', 'interventionNames': ['Drug: Fresh Frozen Plasma blood type 0, A, B and AB']}], 'interventions': [{'name': 'Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate', 'type': 'DRUG', 'description': 'Fibrinogen concentrate Dose: 50 mg/kg BW fibrinogen concentrate if FIBTEM A10\\<7mm Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single vial (1g) over 5 min\n\nProthrombin complex concentrate Dose: 20IE/kg BW PCC if EXTEM CT \\>90sec and FIBTEM A10\\>7mm Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single dose over 10 min\n\nFXIII concentrate Dose: 20 IU/kg BW Fibrogammin® P will be administered with the second dose of fibrinogen concentrate (=100 mg/kg) and if FXIII decreases below 60% as detected by laboratory measurements.\n\nKind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single dose over 10 min', 'armGroupLabels': ['Coagulation factor concentrates']}, {'name': 'Fresh Frozen Plasma blood type 0, A, B and AB', 'type': 'DRUG', 'description': 'Fresh Frozen Plasma Dose: 15ml/kg BW if FibTEM A10 \\<7mm and/or ExTEM CT\\>90sec. Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single U (200mL) over 5 min', 'armGroupLabels': ['Fresh Frozen Plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck / Department for Anesthesia and Intensive Care Medicine', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Univ.-Doz. Dr. Petra Innerhofer', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}