Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 7:10 AM
Study NCT ID:
NCT01779635
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2013-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Heparin-grafted Membrane for CRRT
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': 'D016638', 'term': 'Critical Illness'}], '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': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized initiation with oXiris versus M150 (conventional filter), with cross-over for subsequent circuits.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2013-01-27', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total inotropic score, which is defined as total quantities of Dopamine + Dobutamine + 100 (Noradrenaline) + 100 (Adrenaline) in mcg/kg/min; pre- and post- use of the circuit.', 'timeFrame': 'usually after 10-30 hours of circuit lifespan', 'description': 'effect on hemodynamics'}, {'measure': 'Urine output over the 6 hours preceding the commencement of first circuit, and 6 hours after termination of the first circuit.', 'timeFrame': 'Usually after 10-30 hours of circuit lifespan', 'description': 'effect on oliguria'}], 'primaryOutcomes': [{'measure': 'Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150)', 'timeFrame': 'usually 10 - 30 hours from commencement of circuit', 'description': 'Circuit lifespan'}], 'secondaryOutcomes': [{'measure': 'Pre-circuit INR/APTT, and post-circuit INR/APTT 2 hours after termination. (We will be using the 2 hour post-circuit APTT result of the preceding dialyzer, as the pre-circuit APTT for the subsequent dialyzer.', 'timeFrame': 'Usually after 10-30 hours when dialyzer clots', 'description': 'effect on coagulation status'}, {'measure': 'Serum urea/creatinine, and effluent urea/creatinine (paired samples) at 4 hrs from each circuit commencement, to examine "protein layering" and solute clearance.', 'timeFrame': 'Usually 4 hours into circuit commencement', 'description': 'effect on clearance'}, {'measure': 'Transmembrane pressure (TMP), pressure drop across hemodiafilter (PDF), pressure in (PI), will be recorded on hourly basis throughout treatment, as per usual nursing protocol.', 'timeFrame': 'over 10-30 hours of circuit running', 'description': 'effect on circuit pressures'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heparin-grafted membrane', 'Circuit lifespan', 'Continuous renal replacement therapy', 'Anticoagulation free', 'Bleeding risk', 'Acute kidney injury', 'Critical illness'], 'conditions': ['Acute Kidney Injury', 'Hemorrhage', 'Coagulopathy']}, 'referencesModule': {'references': [{'pmid': '22773036', 'type': 'BACKGROUND', 'citation': 'Schetz M, Van Cromphaut S, Dubois J, Van den Berghe G. Does the surface-treated AN69 membrane prolong filter survival in CRRT without anticoagulation? Intensive Care Med. 2012 Nov;38(11):1818-25. doi: 10.1007/s00134-012-2633-x. Epub 2012 Jul 7.'}, {'pmid': '12577144', 'type': 'BACKGROUND', 'citation': 'Uchino S, Fealy N, Baldwin I, Morimatsu H, Bellomo R. Continuous is not continuous: the incidence and impact of circuit "down-time" on uraemic control during continuous veno-venous haemofiltration. Intensive Care Med. 2003 Apr;29(4):575-8. doi: 10.1007/s00134-003-1672-8. Epub 2003 Feb 8.'}, {'pmid': '17472846', 'type': 'BACKGROUND', 'citation': 'Evenepoel P, Dejagere T, Verhamme P, Claes K, Kuypers D, Bammens B, Vanrenterghem Y. Heparin-coated polyacrylonitrile membrane versus regional citrate anticoagulation: a prospective randomized study of 2 anticoagulation strategies in patients at risk of bleeding. Am J Kidney Dis. 2007 May;49(5):642-9. doi: 10.1053/j.ajkd.2007.02.001.'}, {'pmid': '11193272', 'type': 'BACKGROUND', 'citation': 'Tan HK, Baldwin I, Bellomo R. Continuous veno-venous hemofiltration without anticoagulation in high-risk patients. Intensive Care Med. 2000 Nov;26(11):1652-7. doi: 10.1007/s001340000691.'}, {'pmid': '23102533', 'type': 'BACKGROUND', 'citation': 'Chua HR, Baldwin I, Bailey M, Subramaniam A, Bellomo R. Circuit lifespan during continuous renal replacement therapy for combined liver and kidney failure. J Crit Care. 2012 Dec;27(6):744.e7-15. doi: 10.1016/j.jcrc.2012.08.016. Epub 2012 Oct 24.'}, {'pmid': '34519356', 'type': 'DERIVED', 'citation': 'Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that the use of heparin-grafted membrane versus conventional membrane in critically-ill patients with bleeding-risk undergoing continuous renal replacement therapy, will effectively prolong the circuit lifespan, without worsening of the systemic APTT or underlying bleeding risk.', 'detailedDescription': 'Aims and objectives:\n\nWe aim to compare the performance and safety of heparin-grafted AN69 membrane (oXiris, Gambro) with the conventional AN69 membrane (M150, Gambro) without systemic anticoagulation during continuous renal replacement therapy (CRRT), in critically ill patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU), who has moderate bleeding risk and in whom systemic anticoagulation is contraindicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients (age 21 and above) who are admitted to ICUs or CCU and requiring CRRT for acute kidney injury or ESRD Patients who has moderate bleeding risk (see below definitions) Patients with NO systemic or regional circuit anticoagulation Informed consent taken from the patient, or proxy if the former is unable to sign due to medical reasons Anticipated need for prolonged CRRT \\> 3 days\n\n(Moderate bleeding risk criteria:)\n\nModerate bleeding risk is defined by any of the following:\n\n1. Platelet count \\< 100 x 109 mm3 (but \\> 50)\n2. INR \\> 1.5 (but \\< 2.5)\n3. APTT \\> 50 seconds (but \\< 75)\n4. Post-surgery for \\< 48 hours\n5. Post-invasive procedures (eg. Pericardiocentasis) \\< 24 hrs\n6. Post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) \\< 24 hours\n7. Recent internal or gastrointestinal bleeding within 48 hours (should be secured bleeding with no relapse noted)\n\nExclusion Criteria:\n\nPatients with very high bleeding risk (for which they should also fall outside of the below inclusion criteria - see below) Patients who are known to have heparin-induced thrombocytopenia or allergic to heparin Patients with other medical conditions for which heparin is contraindicated. Patients who require systemic anticoagulation for medical indications (We will accept patients who are on prophylactic doses of anticoagulation for DVT prophylaxis) Patients who are pregnant Patients/legally accepted surrogate who decline to consent'}, 'identificationModule': {'nctId': 'NCT01779635', 'acronym': 'CARROM', 'briefTitle': 'Efficacy and Safety of Heparin-grafted Membrane for CRRT', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Continuous Renal Replacement Therapy With Anticoagulation-free Regimen in Bleeding-risk Patients Using oXiris Membrane - CARROM Study', 'orgStudyIdInfo': {'id': 'DSRB 2012/02222'}, 'secondaryIdInfos': [{'id': 'NKFRC/2012/01/11', 'type': 'OTHER_GRANT', 'domain': 'National Kidney Foundation Singapore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oXiris as first filter', 'description': 'Start off the first CRRT circuit with oXiris, then cross-over to M150, then oXiris, then back to M150', 'interventionNames': ['Device: oXiris as first filter']}, {'type': 'OTHER', 'label': 'M150 as first filter', 'description': 'Patients in M150 arm will start off with M150 as first filter for CRRT, then cross-over to oXiris after the former clots, then back to M150, then to oXiris.', 'interventionNames': ['Device: M150 as first filter']}], 'interventions': [{'name': 'oXiris as first filter', 'type': 'DEVICE', 'description': '2 arms - each start off CRRT with either oXiris or M150 as first hemofilter, and then do cross-over to either hemofilters in a sequential manner when the former clots', 'armGroupLabels': ['oXiris as first filter']}, {'name': 'M150 as first filter', 'type': 'DEVICE', 'description': 'start off with M150 as first hemofilter, then cross-over to oXiris when former clots, and then to M150, and then lastly to oXiris', 'armGroupLabels': ['M150 as first filter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119228', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Horng-Ruey Chua, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}