Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-30 @ 6:16 PM
Study NCT ID:
NCT05856903
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2023-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Emicizumab on Activated Clotting Time Using the i-STAT Alinity Analyzer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification of ACT by emicizumab', 'timeFrame': 'Day 0', 'description': 'Modification of the in vitro heparin-induced ACT increase by emicizumab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Activated Clotting Time', 'Hemophilia', 'Emicizumab'], 'conditions': ['Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '30157389', 'type': 'BACKGROUND', 'citation': 'Mahlangu J, Oldenburg J, Paz-Priel I, Negrier C, Niggli M, Mancuso ME, Schmitt C, Jimenez-Yuste V, Kempton C, Dhalluin C, Callaghan MU, Bujan W, Shima M, Adamkewicz JI, Asikanius E, Levy GG, Kruse-Jarres R. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors. N Engl J Med. 2018 Aug 30;379(9):811-822. doi: 10.1056/NEJMoa1803550.'}, {'pmid': '32396619', 'type': 'BACKGROUND', 'citation': 'Lenting PJ. Laboratory monitoring of hemophilia A treatments: new challenges. Blood Adv. 2020 May 12;4(9):2111-2118. doi: 10.1182/bloodadvances.2019000849.'}, {'pmid': '33094895', 'type': 'BACKGROUND', 'citation': 'Lowe A, Kitchen S, Jennings I, Kitchen DP, Woods TAL, Walker ID. Effects of Emicizumab on APTT, FVIII assays and FVIII Inhibitor assays using different reagents: Results of a UK NEQAS proficiency testing exercise. Haemophilia. 2020 Nov;26(6):1087-1091. doi: 10.1111/hae.14177. Epub 2020 Oct 23.'}, {'pmid': '31576396', 'type': 'BACKGROUND', 'citation': 'Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. No abstract available.'}, {'pmid': '35060654', 'type': 'BACKGROUND', 'citation': "Capdevila L, Frere C, Desvages M, Harroche A, Bally C, Abbes A, d'Oiron R, Frenzel L, Borgel D, Lasne D. Emicizumab does not interfere with the activated clotting time. Haemophilia. 2022 Mar;28(2):362-366. doi: 10.1111/hae.14497. Epub 2022 Jan 21."}, {'pmid': '32928650', 'type': 'BACKGROUND', 'citation': 'Isaacs J, Welsby IJ, Schroder JN, Onwuemene OA. Activated Coagulation Time and Hepcon Protamine Titration Device to Manage Unfractionated Heparin During Cardiopulmonary Bypass in a Hemophilia A Patient on Emicizumab. J Cardiothorac Vasc Anesth. 2021 Nov;35(11):3299-3302. doi: 10.1053/j.jvca.2020.08.058. Epub 2020 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'Emicizumab (Hemlibra®) is a subcutaneous hemostatic treatment approved in 2019 for the prophylaxis in severe hemophilia A. Emicizumab is a bispecific monoclonal antibody mimicking factor VIIIa that provides a constant level of coagulation similar to that observed in minor haemophilia A patients whose factor VIII level is 10-15%. Although the correction of plasma coagulation in vivo is only partial, emicizumab strongly shortens the in vitro coagulation times involving the intrinsic pathway such as aPTT(activated partial thromboplastin time).\n\nThe investigators will evaluate the effect of emicizumab on a coagulation test (Activating clotting time (ACT i-STAT Alinity)) used as a point of care device to monitor heparin therapies during cardiac surgeries (cardiopulmonary bypass) and cardiac catheterizations. Because ACT is activated through the intrinsic pathway, it may also be shortened by emicizumab. Prophylactic treatment with emicizumab would make it impossible to use ACT for heparin therapy in a hemophiliac patient benefiting from this treatment.\n\nThe aim of this in vitro study is to assess the effect of emicizumab on the in vitro heparin-induced ACT increase in severe hemophilia A patients treated with emicizumab and in healthy volunteers (measurement on the i- STAT Alinity) thanks to in vitro blood spiking experiments.\n\nSome data have already been published with other ACT devices (Hemochron..) but never with the i-STAT Alinity device which uses a different technology and other reagents.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'see above', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* severe hemophiliacs under emicizumab ( \\> 4 weeks)\n\nExclusion Criteria:\n\n* infusion of factor VIII \\< 5 days\n* patients refusing to participate in the study\n* protected persons\n* anticoagulants'}, 'identificationModule': {'nctId': 'NCT05856903', 'acronym': 'EMISTAT', 'briefTitle': 'Impact of Emicizumab on Activated Clotting Time Using the i-STAT Alinity Analyzer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Impact of Emicizumab on ACT (Activated Clotting Time) Using the i-STAT Alinity Analyzer: In Vitro Study in Severe Hemophiliacs A and Healthy Volunteers', 'orgStudyIdInfo': {'id': '38RC23.0124'}, 'secondaryIdInfos': [{'id': '2023-A00897-38', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe hemophiliac patients under emicizumab', 'interventionNames': ['Diagnostic Test: ACT']}, {'label': 'Healthy volunteers', 'interventionNames': ['Diagnostic Test: ACT']}], 'interventions': [{'name': 'ACT', 'type': 'DIAGNOSTIC_TEST', 'description': 'ACT will be measured :\n\n* after in vitro spiking with unfractionated heparin of blood samples from severe hemophilia A patients already treated with emicizumab\n* after in vitro spiking with unfractionated heparin with or without emicizumab of blood samples from healthy volunteers', 'armGroupLabels': ['Healthy volunteers', 'Severe hemophiliac patients under emicizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Raphaël MARLU', 'role': 'CONTACT', 'email': 'RMarlu@chu-grenoble.fr', 'phone': '0476765487'}], 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Raphaël MARLU, MD', 'role': 'CONTACT', 'email': 'rmarlu@chu-grenoble.fr', 'phone': '33476765487'}], 'overallOfficials': [{'name': 'Raphaël MARLU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Alpes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}