Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 5:03 PM
Study NCT ID:
NCT01053169
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005164', 'term': 'Factor IX'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 445}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-02', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequacy of stopping or preventing bleeding', 'timeFrame': 'Up to 24 hours after treatment'}], 'secondaryOutcomes': [{'measure': 'Transfusions required', 'timeFrame': 'Up to 24 hours after treatment'}, {'measure': 'Clinical trigger for administration of the intervention', 'timeFrame': 'Up to 24 hours after treatment'}, {'measure': 'Mortality', 'timeFrame': 'Up to 24 hours after treatment'}, {'measure': 'International normalized ratio (INR)', 'timeFrame': 'From 3 hours before and up to 24 hours after treatment'}, {'measure': 'Prothrombin time (PT)', 'timeFrame': 'From 3 hours before and up to 24 hours after treatment'}, {'measure': 'Receipt of other blood products and /or hemostatic agents', 'timeFrame': 'Up to 24 hours after treatment'}, {'measure': 'Vital signs', 'timeFrame': 'From 3 hours before and up to 24 hours after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coagulopathy', 'Perioperative bleeding', 'Prothrombin complex', 'Liver disease'], 'conditions': ['Coagulation Protein Disorders', 'Blood Loss, Surgical', 'Perioperative Care']}, 'descriptionModule': {'briefSummary': 'Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coagulopathy due to liver disease or other conditions requiring correction of coagulopathy who require surgical or diagnostic intervention and patients experiencing acute bleeding perioperatively', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (All):\n\nFor all cohorts:\n\n•≥ 16 years of age\n\n* Received treatment with:\n\n * Beriplex® P/N\n * or FFP and Beriplex® P/N (in subsequent order)\n * or FFP only\n* INR and/or PT results available in connection with administration of Beriplex® P/N or FFP:\n\n * within 3 hours directly before and after administration of Beriplex® P/N or FFP\n\nIn case of Beriplex® P/N use subsequent to FFP, additional results of INR and PT between the administration of the two products\n\nCohort P (Prophylaxis Group):\n\n* Chronic liver disease, acute liver failure, or other conditions requiring correction of coagulopathy\n* Coagulopathy (INR \\> 1.4 and/or PT ≥ 3 sec of upper limit of normal \\[ULN\\])\n* Any planned major or minimally invasive procedure, except liver transplantation\n\nCohort T (Treatment Group):\n\n* Acute perioperative bleeding (as assessed by the investigator)\n\nExclusion Criteria:\n\n* Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N\n* Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)'}, 'identificationModule': {'nctId': 'NCT01053169', 'briefTitle': 'Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)', 'orgStudyIdInfo': {'id': 'BE1116_5001'}, 'secondaryIdInfos': [{'id': '1492', 'type': 'OTHER', 'domain': 'CSL Behring'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prophylaxis Cohort', 'description': 'Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention', 'interventionNames': ['Biological: Beriplex® P/N', 'Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N', 'Other: Fresh Frozen Plasma']}, {'label': 'Treatment Cohort', 'description': 'Patients experiencing acute bleeding perioperatively', 'interventionNames': ['Biological: Beriplex® P/N', 'Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N', 'Other: Fresh Frozen Plasma']}], 'interventions': [{'name': 'Beriplex® P/N', 'type': 'BIOLOGICAL', 'otherNames': ['Prothrombin complex concentrate'], 'description': 'Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.', 'armGroupLabels': ['Prophylaxis Cohort', 'Treatment Cohort']}, {'name': 'Fresh Frozen Plasma (FFP) and Beriplex® P/N', 'type': 'BIOLOGICAL', 'otherNames': ['Prothrombin Complex Concentrate'], 'description': 'FFP is administered before Beriplex® P/N. Each treatment is given as an intravenous infusion, with the dosage of each calculated on an individual patient basis.', 'armGroupLabels': ['Prophylaxis Cohort', 'Treatment Cohort']}, {'name': 'Fresh Frozen Plasma', 'type': 'OTHER', 'description': 'Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.', 'armGroupLabels': ['Prophylaxis Cohort', 'Treatment Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blackburn', 'country': 'United Kingdom', 'facility': 'Royal Blackburn Hospital', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'CB23 3RE', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Addenbrokes', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Southhampton', 'country': 'United Kingdom', 'facility': 'Southhampton General Hospital'}], 'overallOfficials': [{'name': 'Pratima Chowdary, MRCP, FRCPath', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}