Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 6:29 AM
Study NCT ID:
NCT03461406
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2018-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sandra.camprubi@grifols.com', 'phone': '+34670923160', 'title': 'Sandra Camprubi Gimenez', 'organization': 'Instituto Grifols, S.A.'}, 'certainAgreement': {'otherDetails': "Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing informed consent form up to 7 days post study completion (Up to approximately 47 days)', 'description': 'Safety population included all participants who received any amount of IP.', 'eventGroups': [{'id': 'EG000', 'title': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 20, 'seriousNumAtRisk': 91, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 13, 'seriousNumAtRisk': 87, 'deathsNumAffected': 2, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Mechanical ventilation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Procedural vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Intra-abdominal fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acquired hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Hemostasis Within 4 Minutes After Treatment Start (T4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.'}, {'id': 'OG001', 'title': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.'}], 'classes': [{'title': 'Parenchymous Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Soft Tissue Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.09', 'groupDescription': 'Hemostasis by 4 Minutes (Parenchymous)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.16', 'groupDescription': 'Hemostasis by 4 Minutes (Soft Tissue)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8'}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment until 4 minutes after treatment start (Day 1)', 'description': "Hemostasis is defined as Grade 0 bleeding per 5-point validated bleeding severity scale (0=no bleeding and 4=Unidentified or inaccessible spurting or gush) at the target bleeding site (TBS) according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT (mITT) population included all participants in the ITT population who meet the intra-operative enrollment criteria, and thus treated with any amount of investigational product (IP). Overall number analyzed are the number of participants with haemostasis by 4 minutes. Number analyzed are the number of participants with parenchymous and soft tissue surgery with data available for analysis. Percentage are rounded off the single decimal point.'}, {'type': 'SECONDARY', 'title': 'Cumulative Percentage of Participants Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.'}, {'id': 'OG001', 'title': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.'}], 'classes': [{'title': 'Parenchymous Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Soft Tissue Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.09', 'groupDescription': 'Hemostasis by 7 Minutes (Parenchymous)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.09', 'groupDescription': 'Hemostasis by 7 Minutes (Soft tissue)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.'}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to 7 minutes after start of treatment (Day 1)', 'description': "Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of participants achieving hemostasis at the TBS by the time points of T7 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants in the ITT population who meet the intra-operative enrollment criteria, and thus treated with any amount of IP. Overall number analyzed are the number of participants with haemostasis by 4 minutes. Number analyzed are the number of participants with parenchymous and soft tissue surgery with data available for analysis. Percentages are rounded off a single decimal point.'}, {'type': 'SECONDARY', 'title': 'Cumulative Percentage of Participants Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.'}, {'id': 'OG001', 'title': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.'}], 'classes': [{'title': 'Parenchymous Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Soft Tissue Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.02', 'groupDescription': 'Hemostasis by 10 Minutes (Parenchymous)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.09', 'groupDescription': 'Hemostasis by 10 Minutes (Soft tissue)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.'}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to 10 minutes after start of treatment (Day 1)', 'description': "Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of participants achieving hemostasis at the TBS by the time points of T10 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants in the ITT population who meet the intra-operative enrollment criteria and thus treated with any amount of IP. Overall number analyzed are the number of participants with haemostasis by 4 minutes. Number analyzed are the number of participants with parenchymous and soft tissue surgery with data available for analysis. Percentages are rounded off a single decimal point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.'}, {'id': 'OG001', 'title': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.'}], 'classes': [{'title': 'Parenchymous Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Soft Tissue Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to 10 minutes after start of treatment and until the time of completion of surgical closure (Day 1)', 'description': "Participants were considered treatment failures if there is a. persistent bleeding at the TBS beyond T4 b. Grade 3 or Grade 4 breakthrough bleeding from the TBS that jeopardizes participant safety according to the investigator's judgment at any moment during the 10-minute observational period and until TClosure c. Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure, or use of study treatment at the TBS beyond T4 and until TClosure d. Rebleeding (Grade ≥1) at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants in the ITT population who meet the intra-operative enrollment criteria and thus treated with any amount of IP. Overall number analyzed are the number of participants with haemostasis by 4 minutes. Number analyzed are the number of participants with parenchymous and soft tissue surgery with data available for analysis. Percentages are rounded off a single decimal point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.'}, {'id': 'FG001', 'title': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Parenchymous Surgery', 'achievements': [{'comment': 'Participants who underwent parenchymous surgery were included.', 'groupId': 'FG000', 'numSubjects': '46'}, {'comment': 'Participants who underwent parenchymous surgery were included.', 'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Soft Tissue Surgery', 'achievements': [{'comment': 'Participants who underwent soft tissue surgery were included.', 'groupId': 'FG000', 'numSubjects': '45'}, {'comment': 'Participants who underwent soft tissue surgery were included.', 'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Safety Population', 'comment': 'Safety population included all participants who received any amount of IP.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Consent Withdrawn by Participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 18 sites in the United States, Bulgaria, France, Hungary, Romania, Serbia, and United Kingdom, from 18 January 2019 (first participant enrolled to receive the study drug) to 20 May 2022 (last participant completed).', 'preAssignmentDetails': 'Paediatric participants with excessive bleeding during surgery were randomized into 1: 1 ratio to receive Fibrin Sealant (FS) Grifols and EVICEL. A total of 197 participants were screened, out of which 186 participants were randomized (Intent-to-treat population), 178 received study treatment (modified intent-to-treat population), 171 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.'}, {'id': 'BG001', 'title': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.43', 'spread': '6.108', 'groupId': 'BG000'}, {'value': '8.84', 'spread': '6.320', 'groupId': 'BG001'}, {'value': '8.63', 'spread': '6.199', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all participants who were randomized, regardless of meeting intra-operative enrollment criteria and regardless of whether the IP was administered to the participant.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-11', 'size': 935627, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-24T07:31', 'hasProtocol': True}, {'date': '2020-11-02', 'size': 596669, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-24T07:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2018-03-02', 'resultsFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-14', 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hemostasis Within 4 Minutes After Treatment Start (T4)', 'timeFrame': 'From start of treatment until 4 minutes after treatment start (Day 1)', 'description': "Hemostasis is defined as Grade 0 bleeding per 5-point validated bleeding severity scale (0=no bleeding and 4=Unidentified or inaccessible spurting or gush) at the target bleeding site (TBS) according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin."}], 'secondaryOutcomes': [{'measure': 'Cumulative Percentage of Participants Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7)', 'timeFrame': 'From start of treatment to 7 minutes after start of treatment (Day 1)', 'description': "Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of participants achieving hemostasis at the TBS by the time points of T7 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure."}, {'measure': 'Cumulative Percentage of Participants Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10)', 'timeFrame': 'From start of treatment to 10 minutes after start of treatment (Day 1)', 'description': "Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of participants achieving hemostasis at the TBS by the time points of T10 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure."}, {'measure': 'Percentage of Participants With Treatment Failures', 'timeFrame': 'From start of treatment to 10 minutes after start of treatment and until the time of completion of surgical closure (Day 1)', 'description': "Participants were considered treatment failures if there is a. persistent bleeding at the TBS beyond T4 b. Grade 3 or Grade 4 breakthrough bleeding from the TBS that jeopardizes participant safety according to the investigator's judgment at any moment during the 10-minute observational period and until TClosure c. Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure, or use of study treatment at the TBS beyond T4 and until TClosure d. Rebleeding (Grade ≥1) at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Excessive Bleeding During Surgery']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).', 'detailedDescription': "This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery. Approximately 172 pediatric participants will be enrolled and will be randomly allocated in a 1:1 ratio into 1 of 2 treatment groups: FS Grifols or EVICEL. Enrollment will be monitored by surgery type to ensure at least 50% of the surgical procedures are hepatic.\n\nA specific bleeding site will be defined as the TBS when it is determined by the investigator (the surgeon) that control of bleeding by conventional surgical techniques (including suture, ligature, and cautery) is ineffective or impractical and requires an adjunct treatment to achieve hemostasis.\n\nWhen the TBS is identified, the investigator will record the precise anatomical location of the TBS, rate the intensity of the bleeding at the TBS (Grade 1-4 according to a 5-point validated bleeding severity scale), and record the size of the approximate bleeding surface, (small, medium, and large). For soft tissue surgery only, the investigator will also record the type of soft tissue (ie, fat, muscle, or connective tissue). In this clinical trial, only participants with a TBS with bleeding of Grade 1 (mild) or Grade 2 (moderate) intensity will be enrolled.\n\nThis study includes a Screening Visit to determine participant eligibility, a Baseline Visit, the Surgical Procedure (Day 1), and Post-operative assessments at Days 1, 4, and 30. The total duration of a participant's participation in this study is expected to be no longer than 2 months from the Screening Visit to the Post-operative Day 30 Visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPre-operative:\n\n1. Less than 18 years of age.\n2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure.\n3. Participant and/or participant's legal guardian is willing to give permission for the participant to participate in the clinical trial and provide written informed consent for the participant. In addition, assent must be obtained from pediatric participants who possess the intellectual and emotional ability to comprehend the concepts involved in the clinical trial.\n\n Intra-operative:\n4. Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft tissue TBS identified intra-operatively by the investigator (the surgeon).\n5. TBS has Grade 1 (mild) or Grade 2 (moderate) bleeding intensity according to the investigator's (the surgeon's) judgment. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale.\n\nExclusion Criteria:\n\nPre-operative:\n\n1. Admitted for trauma surgery.\n2. Unwilling to receive blood products.\n3. Known history of severe (eg, anaphylactic) reaction to blood products.\n4. Known history of intolerance to any of the components of the investigational product (IP).\n5. Female participants who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception.\n6. Previously enrolled in a clinical trial with FS Grifols.\n7. Currently participating, or during the study is planned to participate, in any other investigational device or medicinal product study without prior and explicit approval from the sponsor.\n\n Intra-operative:\n8. An appropriate parenchymous or soft tissue TBS (as defined in exclusion criteria 9 and 10) cannot be identified intra-operatively by the investigator (the surgeon).\n9. TBS has Grade 3 (severe) bleeding according to the investigator's (the surgeon's) judgment that cannot be controlled with conventional surgical techniques to Grade 1 or Grade 2 bleeding. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale.\n10. TBS is in an actively infected surgical field.\n11. Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.\n12. Application of any topical hemostatic agent on the resection surface of parenchyma or soft tissue prior to application of the IP."}, 'identificationModule': {'nctId': 'NCT03461406', 'briefTitle': 'A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grifols Therapeutics LLC'}, 'officialTitle': 'A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects', 'orgStudyIdInfo': {'id': 'IG1405'}, 'secondaryIdInfos': [{'id': '2016-004489-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fibrin Sealant Grifols', 'description': 'Participants topically applied FS Grifols, which consisted of component 1: human fibrinogen (80 mg/mL) and component 2: human thrombin with calcium chloride (500 IU/mL) solutions filled in syringes and assembled on a syringe holder.', 'interventionNames': ['Biological: Fibrin Sealant Grifols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EVICEL', 'description': 'Participants topically applied EVICEL, which consisted of component 1: Concentrate of human fibrinogen (BAC 2) (55-85 mg/mL) and component 2: human thrombin (800-1200 IU/mL) solutions. The 2 components (BAC2 and thrombin) were mixed and applied topically.', 'interventionNames': ['Biological: EVICEL']}], 'interventions': [{'name': 'Fibrin Sealant Grifols', 'type': 'BIOLOGICAL', 'otherNames': ['FS Grifols'], 'description': 'The FE Grifols solution was applied topically via drip or spray application.', 'armGroupLabels': ['Fibrin Sealant Grifols']}, {'name': 'EVICEL', 'type': 'BIOLOGICAL', 'description': 'The EVICEL solution was applied topically via drip or spray application.', 'armGroupLabels': ['EVICEL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Lurie Childrens Hospital of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48109', 'city': 'Michigan Center', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.23309, 'lon': -84.32718}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'The Urological Institute of Northeastern New York', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'St. Christophers Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': "MUSC Health-Children's Hospital", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Le Bonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Childrens Hospital', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Memorial City', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24013', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': "Carilion Children's Pediatric Surgery", 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '3400', 'city': 'Montana', 'country': 'Bulgaria', 'facility': 'MHAT City clinic - 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