Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 8:17 AM
Study NCT ID:
NCT06020560
Status:
UNKNOWN
Last Update Posted:
2023-08-31
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Low Molecular Weight Heparins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-03-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pregnancy loss', 'timeFrame': '9 months', 'description': 'Risk of pregnancy loss during treatment with either of the two drugs studied'}, {'measure': 'Stillbirth', 'timeFrame': '9 months', 'description': 'Risk of stillbirth during treatment with either of the two drugs studied'}, {'measure': 'Antepartum bleeding', 'timeFrame': '9 months', 'description': 'Risk of antepartum bleeding during treatment with either of the two drugs studied'}, {'measure': 'Postpartum bleeding', 'timeFrame': 'up to 365 days', 'description': 'Risk of postpartum bleeding during treatment with either of the two drugs studied'}, {'measure': 'Placental complications', 'timeFrame': '9 months', 'description': 'Risk of placental complications (Abruptio placenta, placenta prevue) during treatment with either of the two drugs studied'}, {'measure': 'Preeclampsia', 'timeFrame': '9 months', 'description': 'Risk of preeclampsia and eclampsia during treatment with either of the two drugs studied'}], 'primaryOutcomes': [{'measure': '30-day all-cause mortality and bleeding requiring blood transfusion', 'timeFrame': '30 days', 'description': 'To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring blood transfusion during admission or death within 30 days in patients with indication for low molecular weight heparins.'}], 'secondaryOutcomes': [{'measure': '30-day all-cause mortality', 'timeFrame': '30 days', 'description': 'Risk of all-cause mortality within 30 days of administering one of the studied drugs'}, {'measure': '365-day all-cause mortality', 'timeFrame': '365 days', 'description': 'Risk of all-cause mortality within 365 days of administering one of the studied drugs'}, {'measure': 'Blood transfusion during admission', 'timeFrame': '90 days', 'description': 'Blood transfusion defined from use of blood products'}, {'measure': '90 day risk of pulmonary embolism', 'timeFrame': '90 days', 'description': 'Risk of pulmonary embolism within 90 days of administering one of the drugs studied'}, {'measure': '90 day risk of deep venous thrombosis', 'timeFrame': '90 days', 'description': 'Risk of pulmonary embolism within 90 days of administering one of the drugs studied'}, {'measure': 'Heparin induced thrombocytopenia', 'timeFrame': '90 days', 'description': 'Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies'}, {'measure': 'Liver failure', 'timeFrame': '90 days', 'description': 'Risk of liver failure defined by ALAT 3X upper limit of normal'}, {'measure': 'Length of hospital admission', 'timeFrame': 'Admission time (up to 1 year from inclusion measured in days)', 'description': 'Length of hospital admission'}, {'measure': 'Days alive out of hospital', 'timeFrame': 'Time out of hospital (up to 1 year from inclusion measured in days)', 'description': 'Days alive out of hospital'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anticoagulant', 'Venous Thromboembolism', 'Prophylaxis', 'Treatment']}, 'descriptionModule': {'briefSummary': 'DANHEP is a cluster randomized study of two different low molecular weight heparins. Parenteral anticoagulants are used in a variety of settings, including treatment and prevention of venous thromboembolism in cancer patients, medical patients, and surgical patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently used parenteral anticoagulants in Denmark, include the two different low molecular weight heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is a lack of evidence regarding whether these drugs are in fact comparable. The aim of this study is therefore to investigate the comparative safety and efficacy of the two different low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in patients with an indication for low molecular weight heparins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with indication for low molecular weight heparin\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* Patients who are incapable of understanding the written material received\n* Patients who after being informed in writing chooses not to participate\n* Patients with contraindications for low molecular weight heparins as described in the SmPC'}, 'identificationModule': {'nctId': 'NCT06020560', 'acronym': 'DANHEP', 'briefTitle': 'Study of Low Molecular Weight Heparins', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC', 'orgStudyIdInfo': {'id': 'DANHEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dalteparin', 'interventionNames': ['Drug: Tinzaparin profiled syringe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tinzaparin', 'interventionNames': ['Drug: Dalteparin Prefilled Syringe']}], 'interventions': [{'name': 'Dalteparin Prefilled Syringe', 'type': 'DRUG', 'description': 'Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.', 'armGroupLabels': ['Tinzaparin']}, {'name': 'Tinzaparin profiled syringe', 'type': 'DRUG', 'description': 'Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.', 'armGroupLabels': ['Dalteparin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henriette Svarre, Professor, MD', 'role': 'CONTACT', 'email': 'Henriette.Svarre.Nielsen@regionh.dk'}], 'facility': 'Amager-Hvidovre Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Søren Overgaard, Professor, MD', 'role': 'CONTACT'}], 'facility': 'Frederiksberg and Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lars Køber, Professor, MD', 'role': 'CONTACT', 'email': 'Lars.Koeber.01@regionh.dk'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kasper K Iversen, MD, DMsc', 'role': 'CONTACT', 'email': 'Kasper.Karmark.Iversen@regionh.dk'}], 'facility': 'Herlev and Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Bestle, Professor, MD', 'role': 'CONTACT', 'email': 'Morten.Bestle@regionh.dk'}], 'facility': 'Nordsjællands Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'city': 'Nykøbing Falster', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jacob Fyhring Mortensen, MD', 'role': 'CONTACT'}, {'name': 'Jmot@regionsjaelland.dk', 'role': 'CONTACT'}], 'facility': 'Nykøbing Falster Hospital', 'geoPoint': {'lat': 54.76906, 'lon': 11.87425}}, {'city': 'Næstved', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik Stig Jørgensen, MD', 'role': 'CONTACT', 'email': 'henjor@regionsjaelland.dk'}], 'facility': 'Næstved, Ringsted, Slagelse Hospital', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'city': 'Roskilde', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lasse Bremholm', 'role': 'CONTACT', 'email': 'labha@regionsjaelland.dk'}], 'facility': 'Roskilde, Køge Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'city': 'Rønne', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Diana Kaiser', 'role': 'CONTACT', 'email': 'diana.utech.kaiser@regionh.dk'}], 'facility': 'Bornholm Hospital', 'geoPoint': {'lat': 55.10091, 'lon': 14.70664}}], 'centralContacts': [{'name': 'Kasper Iversen, Professor, MD', 'role': 'CONTACT', 'email': 'Kasper.Karmark.Iversen@regionh.dk', 'phone': '+ 45 28712753'}, {'name': 'Lars Køber, Professor, MD', 'role': 'CONTACT', 'email': 'lars.koeber01@regionh.dk', 'phone': '+ 45 35458525'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Kasper Iversen', 'investigatorAffiliation': 'Herlev Hospital'}}}}