Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-02 @ 7:07 AM
Study NCT ID:
NCT03536195
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2018-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Renal Replacement Therapy on Coagulation Profile of Patients with Acute Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visco elastometry', 'timeFrame': 'Change in ROTEM parameters from baseline to after renal replacement therapy', 'description': 'ROTEM (Rotational Thromboelastometry)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal replacement therapy', 'acute renal failure', 'coagulation', 'bleeding'], 'conditions': ['Acute Renal Failure', 'Hemorrhage', 'Coagulation Disorder']}, 'descriptionModule': {'briefSummary': 'Renal failure and high plasmatic level of urea have been associated with an increased risk of hemorrhage in surgical patients. There is only sparse data on the impact of renal replacement therapy on homeostatic parameters. The aim of this study is to describe potential changes in homeostatic parameters before and after renal replacement therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients with acute renal failure where the decision of renal replacement therapy has been made.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill patients\n* acute renal failure\n* renal replacement therapy\n* plasmatic urea \\> 20\n\nExclusion Criteria:\n\n* chronic renal failure\n* platelet count less than 80 Giga\n* V factor less than 70%'}, 'identificationModule': {'nctId': 'NCT03536195', 'acronym': 'HEMOSTIR', 'briefTitle': 'Impact of Renal Replacement Therapy on Coagulation Profile of Patients with Acute Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Impact of Renal Replacement Therapy on Coagulation Profile in Patients with Acute Renal Failure', 'orgStudyIdInfo': {'id': 'HEMOSTIR (29BRC17.0132)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}