Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-10 @ 9:38 AM
Study NCT ID:
NCT02461251
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in blood transfusions', 'timeFrame': '24 h'}], 'secondaryOutcomes': [{'measure': 'Reduction of transfusion related side-effects', 'timeFrame': '30 days'}, {'measure': 'Number of thromboembolic events', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thromboelastometry', 'Obstetric Hemorrhage', 'Blood Component Transfusion'], 'conditions': ['Obstetric Labor Complications', 'Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '36496259', 'type': 'DERIVED', 'citation': 'Jokinen S, Kuitunen A, Uotila J, Yli-Hankala A. Thromboelastometry-guided treatment algorithm in postpartum haemorrhage: a randomised, controlled pilot trial. Br J Anaesth. 2023 Feb;130(2):165-174. doi: 10.1016/j.bja.2022.10.031. Epub 2022 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized and controlled study to find out if a rotational thromboelastometry(ROTEM) guided treatment protocol reduces the need for blood transfusions in major obstetric haemorrhage compared to standard care of clinical decision making, conventional coagulation tests and massive transfusion protocol. Secondary aim is to find out if ROTEM can predict the incidence of thromboembolic events in this patient group.', 'detailedDescription': "A comparison of two different treatment protocols is made in patients suffering major obstetric haemorrhage: those who after a normal delivery are bleeding more than 1000 ml and are in need of surgical intervention to control the bleeding and those in cesarean section with ongoing bleeding of more than 1000 ml. Patients are randomized in to two groups: the control group(n=30) will be treated according to a protocol based on clinical decision making, standard coagulation tests and massive transfusion packages of blood products(1:1:1), if needed. This is referred as 'Standard care' in this hospital. The intervention group(n=30) will be treated according to a rotational thromboelastometry guided protocol, and massive transfusion packages, if needed. The study is powered to detect a reduction of one unit in red blood cell transfusion. Blood product, fibrinogen concentrate, prothrombin complex concentrate usage and total amount of blood loss will be compared, and the number of transfusion related side effects and thromboembolic events 30 days after the bleeding will be recorded."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age over 18\n* Severe post-partum haemorrhage ie. active bleeding of more than 1000ml within 24 hours after vaginal delivery or cesarean section\n* Informed consent (after randomization)\n\nExclusion Criteria:\n\n* Known hemophilia or von Willebrand's disease\n* Unacceptance of allogeneic blood products(Jehovah's witnesses)"}, 'identificationModule': {'nctId': 'NCT02461251', 'acronym': 'ROTEM-PPH', 'briefTitle': 'Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients', 'orgStudyIdInfo': {'id': 'ETL R15054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotational thromboelastometry (ROTEM)', 'description': 'Rotational thromboelastometry results are used to guide the treatment of major obstetric hemorrhage, eg. administration of prothrombin complex concentrate, fresh-frozen plasma, fibrinogen concentrate or platelets. In case of massive hemorrhage, "shock packs" of blood products in 1:1:1 ratio are administered.', 'interventionNames': ['Device: Rotational Thromboelastometry (ROTEM)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Patients are treated according to clinical decision making and conventional coagulation tests, and in case of massive hemorrhage, "shock packs" are administered.'}], 'interventions': [{'name': 'Rotational Thromboelastometry (ROTEM)', 'type': 'DEVICE', 'description': 'A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.', 'armGroupLabels': ['Rotational thromboelastometry (ROTEM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33560', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Anne Kuitunen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Samuli Jokinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}