Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05926518
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-28', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of anti-Xa peak level', 'timeFrame': '2 years', 'description': 'U/ml'}], 'secondaryOutcomes': [{'measure': 'Percentage of anti-Xa levels within target range', 'timeFrame': '2 years', 'description': 'Amount of levels within target range (in %)'}, {'measure': 'Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level', 'timeFrame': '2 years', 'description': 'relevant correlation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Therapeutic Drug Monitoring', 'Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients.\n\nSecondary objectives\n\n1. To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups.\n2. To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult ICU patients (COVID-19 and non-COVID-19 patients) using nadroparin with the intention of thrombosis prophylaxis are included. Anti Xa activity is determined once per patient at least 3 days (peak level after 4th administration) after admission at the ICU and on nadroparin treatment. No randomization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All COVID-19 patients \\> 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc\n* All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc.\n* Minimum estimated length of stay on the ICU of 4 days\n\nExclusion Criteria:\n\no (History of) Heparin Induced Thrombocytopenia and Thrombosis'}, 'identificationModule': {'nctId': 'NCT05926518', 'acronym': 'NADRO', 'briefTitle': 'Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU', 'orgStudyIdInfo': {'id': '2020/1725'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 ICU patients', 'description': 'Patients were administered as standard care once daily nadroparin 5700 IU sc (below 100 kg) or twice daily nadroparin 5700 IU sc (above 100 kg).', 'interventionNames': ['Procedure: blood sampling']}, {'label': 'non-COVID-19 ICU patients', 'description': 'Patients were administered as standard care once daily nadroparin 2850 IU sc.', 'interventionNames': ['Procedure: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'PROCEDURE', 'description': 'Blood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc.', 'armGroupLabels': ['COVID-19 ICU patients', 'non-COVID-19 ICU patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815 AD', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Monique de Maat', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}