Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-04-18 @ 5:18 AM
Study NCT ID:
NCT01938768
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2013-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2013-09-05', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial state of hyperfibrinolysis', 'timeFrame': 'Minutes after arrival on the scene', 'description': 'State of hyperfibrinolysis quantified by thromelastometry and PAP-Complex (Plasmin-Antiplasmin-Complex) from a blood sample taken a soon as possible on the scene'}, {'measure': 'State of hyperfibrinolysis on hospital admission', 'timeFrame': 'minutes to hours after incident', 'description': 'State of hyperfibrinolysis quantified by thrombelastometry and PAP-Complex from a blood sample taken as soon as possible after hospital arrival'}], 'secondaryOutcomes': [{'measure': 'transfusion of packed red blood cells', 'timeFrame': '48 hours', 'description': 'units of packed RBC units transfused within 48 hours after hospital admission'}, {'measure': 'substitution of coagulation products', 'timeFrame': '48 hours after hospital admission', 'description': 'number and type of coagulation products given within 48 hours after hospital admission'}, {'measure': 'length of stay intensive care unit (LOS ICU)', 'timeFrame': 'one year', 'description': 'length of the first ICU stay'}, {'measure': 'length of hospital stay', 'timeFrame': 'one year', 'description': 'length of stay in the acute care hospital (not rehabilitation facilities)'}, {'measure': 'mortality', 'timeFrame': '90 days', 'description': 'dead within 90 days after hospital admission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple trauma', 'Polytrauma', 'Hyperfibrinolysis', 'Tranexamic acid', 'Thrombelastometry'], 'conditions': ['Hyperfibrinolysis', 'Haemorrhage', 'Mortality']}, 'referencesModule': {'references': [{'pmid': '19590321', 'type': 'BACKGROUND', 'citation': 'Schochl H, Frietsch T, Pavelka M, Jambor C. Hyperfibrinolysis after major trauma: differential diagnosis of lysis patterns and prognostic value of thrombelastometry. J Trauma. 2009 Jul;67(1):125-31. doi: 10.1097/TA.0b013e31818b2483.'}, {'pmid': '20554319', 'type': 'BACKGROUND', 'citation': 'CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.'}, {'pmid': '21439633', 'type': 'BACKGROUND', 'citation': 'CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.'}, {'pmid': '27724970', 'type': 'DERIVED', 'citation': 'Kunze-Szikszay N, Krack LA, Wildenauer P, Wand S, Heyne T, Walliser K, Spering C, Bauer M, Quintel M, Roessler M. The pre-hospital administration of tranexamic acid to patients with multiple injuries and its effects on rotational thrombelastometry: a prospective observational study in pre-hospital emergency medicine. Scand J Trauma Resusc Emerg Med. 2016 Oct 10;24(1):122. doi: 10.1186/s13049-016-0314-4.'}]}, 'descriptionModule': {'briefSummary': 'Severe external and internal bleedings are common in multiple trauma patients. Uncontrollable blood loss is the cause for about one third of all trauma deaths. A number of blood clotting mechanisms are known to be triggered by major blood losses. These mechanisms shall secure the organisms from loosing even more blood. To avoid an overshooting clotting behavior, inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic) mechanism is the fibrinolysis that is based on the conversion of plasminogen to plasmin. In severe bleeding situations this mechanism tends to overshoot and therewith contributes to the severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in approximately one third of all multiple trauma patients. Mortality rates are increased in these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion from plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A large study showed positive influence of tranexamic acid on mortality rates and blood loss in severely injured patients, when it was administered in an early clinical setting. In this study we want to answer the question wether a hyperfibrinolysis can be seen in an early prehospital (on the scene) setting and how it is influenced by an early prehospital administration of tranexamic acid.', 'detailedDescription': 'In patients suffering from multiple trauma the initially responding emergency physician on the scene will take a blood sample for thrombelastometry immediately after i.v. access is established. According to the initial trauma life support protocols a number of patients will receive a dose of tranexamic acid during the initial treatment on the scene or during transport to the hospital. A second blood sample will be taken after arrival in the resuscitation area of the hospital. Thrombelastometric measurements will be performed with both blood samples and the extent of hyperfibrinolysis in both samples will be compared. In a second step the outcome of the patients who received tranexamic acid on the scene will be compared to those who did not receive the drug before reaching hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited by emergency physicians on the scene by taking a blood sample for thrombelastometry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple trauma ISS \\> 15\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* No informed consent\n* Inclusion to an interventional clinical trial\n* Death of the patient on the scene or before the hospital was reached\n* Delayed thrombelastometric measurement (\\> 4 hours)'}, 'identificationModule': {'nctId': 'NCT01938768', 'briefTitle': 'Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'orgStudyIdInfo': {'id': 'ZARI-NK-2013-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tranexamic acid', 'description': 'patients with multiple trauma who received tranexamic acid on the scene'}, {'label': 'Non tranexamic acid', 'description': 'patients with multiple trauma who did not receive tranexamic acid on the scene'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'University Medical Center Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'overallOfficials': [{'name': 'Quintel Michael, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Goettingen'}, {'name': 'Roessler Markus, PD Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Goettingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tem International GmbH, München, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. med. Nils Kunze', 'investigatorAffiliation': 'University of Göttingen'}}}}