Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02784951
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012771', 'term': 'Shock, Hemorrhagic'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004906', 'term': 'Erythrocyte Count'}, {'id': 'C020332', 'term': 'formycin diphosphate'}], 'ancestors': [{'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adverse transfusion reactions', 'timeFrame': '24 hours', 'description': 'Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.'}, {'measure': 'patients included', 'timeFrame': '24 hours', 'description': 'Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products'}, {'measure': 'units not used', 'timeFrame': '24 hours', 'description': 'Fraction of prepared plasma or blood units not used.'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': '24 hours', 'description': 'Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))'}, {'measure': 'Type of adverse events', 'timeFrame': '24 hours', 'description': 'Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))'}, {'measure': 'number of transfusion', 'timeFrame': '24 hours', 'description': 'Number of transfusions given prehospital and inhospital (first 24 hrs)'}, {'measure': 'type of transfusion', 'timeFrame': '24 hours', 'description': 'type of transfusions given prehospital and inhospital (first 24 hrs)'}, {'measure': 'Systolic blood pressure (SBP)', 'timeFrame': '24 hours', 'description': 'Systolic blood pressure (SBP) on scene and at admission hospital'}, {'measure': 'heart rate (HR)', 'timeFrame': '24 hours', 'description': 'heart rate (HR) on scene and at admission hospital'}, {'measure': 'Glasgow Coma Score (GCS)', 'timeFrame': '24 hours', 'description': 'Glasgow Coma Score (GCS) on scene and at admission hospital'}, {'measure': 'Respiratory rate (RR)', 'timeFrame': '24 hours', 'description': 'Respiratory rate (RR) on scene and at admission hospital'}, {'measure': 'Pulse oximeter (SPO2)', 'timeFrame': '24 hours', 'description': 'Pulse oximeter (SPO2) on scene and at admission hospital'}, {'measure': 'response time (minutes)', 'timeFrame': '24 hours', 'description': 'Physician staffed emergency medical services response (in minutes) from dispatch to arrival on-scene'}, {'measure': 'on-scene time (minutes)', 'timeFrame': '24 hours', 'description': 'Time (in minutes) from emergency medical services arrival on-scene until patients leaves the scene or is pronounced dead on-scene'}, {'measure': 'transport time (minutes)', 'timeFrame': '24 hours', 'description': 'Time (in minutes) from the patients leaves the scene until patient arrives in hospital'}, {'measure': 'Number of surgical interventions', 'timeFrame': '24 hours', 'description': 'Number of surgical interventions (first 24 hrs)'}, {'measure': 'Type of surgical interventions', 'timeFrame': '24 hours', 'description': 'type of surgical interventions (first 24 hrs)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemorrhagic Shock']}, 'referencesModule': {'references': [{'pmid': '36494743', 'type': 'DERIVED', 'citation': 'Sunde GA, Bjerkvig C, Bekkevold M, Kristoffersen EK, Strandenes G, Bruserud O, Apelseth TO, Heltne JK. Implementation of a low-titre whole blood transfusion program in a civilian helicopter emergency medical service. Scand J Trauma Resusc Emerg Med. 2022 Dec 9;30(1):65. doi: 10.1186/s13049-022-01051-z.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety.', 'detailedDescription': 'This study evaluates prehospital transfusion therapy in exsanguinating patients treated by physician-staffed emergency medical services in Norway, with the following main questions:\n\nI. Are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions?\n\nII. Is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible?\n\nIII. Are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment?\n\nIV. Are out-of-hospital transfusion practices associated with increased waste of blood products?\n\nAll patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products will be included, if they fulfill the listed criteria below:\n\n* Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)\n* Radial pulse \\> 100 beats/min or absent/weak radial pulse\n* Systolic blood pressure (SBP) \\< 90 mmHg\n* Altered mental status (reduced GCS) in the absence of head injury or known intoxication\n\nPatients with known previous serious allergic reactions to blood product transfusions or patients who refuse blood products on religious grounds (e.g. Jehovah´s Witness) will be excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients (pediatric and adult) in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products by treating physician staffed emergency medical services.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products according to listed indicators below:\n\n * Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)\n * Radial pulse \\> 100 beats/min or absent/weak radial pulse\n * Systolic blood pressure (SBP) \\< 90 mmHg\n * Altered mental status (reduced GCS) in the absence of head injury or known intoxication\n\nExclusion Criteria:\n\n* Patients with known previous serious allergic reactions to blood product transfusions\n* Patients who refuse blood products on religious grounds, e.g. Jehovah´s Witness'}, 'identificationModule': {'nctId': 'NCT02784951', 'acronym': 'ProHEMS', 'briefTitle': 'Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Use of Blood and Plasma in Prehospital Haemorrhagic Shock - a Prospective, Observational Trial of Advanced Deployment of Blood Products in Norwegian Physician-staffed Helicopter Emergency Medical System', 'orgStudyIdInfo': {'id': '2016/304/REK vest'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single group', 'description': 'Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB).', 'interventionNames': ['Drug: Red blood cells (0Rh D-neg)', 'Drug: Whole blood (O Rh D-neg K-neg)', 'Drug: Freeze dried plasma (LyoPlas)']}], 'interventions': [{'name': 'Red blood cells (0Rh D-neg)', 'type': 'DRUG', 'otherNames': ['RBC'], 'description': 'Fresh produced RBC', 'armGroupLabels': ['Single group']}, {'name': 'Whole blood (O Rh D-neg K-neg)', 'type': 'DRUG', 'otherNames': ['WB'], 'description': 'Fresh produced WB', 'armGroupLabels': ['Single group']}, {'name': 'Freeze dried plasma (LyoPlas)', 'type': 'DRUG', 'otherNames': ['FDP'], 'description': '(LyoPlas N-w (German Red Cross)', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4809', 'city': 'Arendal', 'country': 'Norway', 'facility': 'Sørlandet Hospital HF', 'geoPoint': {'lat': 58.46151, 'lon': 8.77253}}, {'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '2380', 'city': 'Brumunddal', 'country': 'Norway', 'facility': 'Innlandet Hospital Trust', 'geoPoint': {'lat': 60.88095, 'lon': 10.93948}}, {'zip': '3004', 'city': 'Drammen', 'country': 'Norway', 'facility': 'Vestre Viken Hospital Trust', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'zip': '6807', 'city': 'Førde', 'country': 'Norway', 'facility': 'Helse Førde', 'geoPoint': {'lat': 61.45217, 'lon': 5.85717}}, {'zip': '0450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '8100', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Helse Stavanger HF', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'zip': '9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olav University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Hanne Klausen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director, Kirurgisk Serviceklinikk, Haukeland Universitetssykehus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Helse Forde', 'class': 'OTHER'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}