Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-11 @ 7:42 PM
Study NCT ID:
NCT01849757
Status:
WITHDRAWN
Last Update Posted:
2019-05-03
First Post:
2013-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C017577', 'term': 'normosol R'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'C048013', 'term': 'Plasmalyte A'}, {'id': 'D000075462', 'term': 'Serum Albumin, Human'}, {'id': 'C067831', 'term': "zidovudine 5'-monophosphate-mannose-albumin conjugate"}, {'id': 'C485123', 'term': 'HES 130-0.4'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Pentaspan is no longer used at our institution. Pentaspan was an arm of the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-30', 'studyFirstSubmitDate': '2013-05-06', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative bleeding and transfusion requirements', 'timeFrame': '24-48 hours post-operatively', 'description': 'Postoperative cardiac patients have chest tubes in place which drain any blood oozing from around the pericardial cavity. The chest tubes are attached to a blood collection apparatus which measures the amount of blood loss. Too much post-operative blood loss results in a transfusion requirement of red blood cells, plasma and/or platelets.'}], 'secondaryOutcomes': [{'measure': 'renal function, creatinine levels', 'timeFrame': '24-48 hours post-operatively', 'description': 'Use of some colloids have been associated with a deterioration of renal function. Data will be collected post-operatively to determine he effect of the different priming fluids on renal function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary bypass', 'prime', 'crystalloid', 'albumin', 'HES 130/0.4'], 'conditions': ['Coronary Artery Disease', 'Aortic Valve Disease', 'Mitral Valve Disease']}, 'referencesModule': {'references': [{'pmid': '23075127', 'type': 'BACKGROUND', 'citation': 'Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, Glass P, Lipman J, Liu B, McArthur C, McGuinness S, Rajbhandari D, Taylor CB, Webb SA; CHEST Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med. 2012 Nov 15;367(20):1901-11. doi: 10.1056/NEJMoa1209759. Epub 2012 Oct 17.'}, {'pmid': '22578894', 'type': 'BACKGROUND', 'citation': 'Navickis RJ, Haynes GR, Wilkes MM. Effect of hydroxyethyl starch on bleeding after cardiopulmonary bypass: a meta-analysis of randomized trials. J Thorac Cardiovasc Surg. 2012 Jul;144(1):223-30. doi: 10.1016/j.jtcvs.2012.04.009. Epub 2012 May 9.'}, {'pmid': '21989733', 'type': 'BACKGROUND', 'citation': 'Hartog CS, Reuter D, Loesche W, Hofmann M, Reinhart K. Influence of hydroxyethyl starch (HES) 130/0.4 on hemostasis as measured by viscoelastic device analysis: a systematic review. Intensive Care Med. 2011 Nov;37(11):1725-37. doi: 10.1007/s00134-011-2385-z. Epub 2011 Oct 12.'}, {'pmid': '19095827', 'type': 'BACKGROUND', 'citation': 'Schramko AA, Suojaranta-Ylinen RT, Kuitunen AH, Kukkonen SI, Niemi TT. Rapidly degradable hydroxyethyl starch solutions impair blood coagulation after cardiac surgery: a prospective randomized trial. Anesth Analg. 2009 Jan;108(1):30-6. doi: 10.1213/ane.0b013e31818c1282.'}, {'pmid': '23228215', 'type': 'BACKGROUND', 'citation': 'Akkucuk FG, Kanbak M, Ayhan B, Celebioglu B, Aypar U. The effect of HES (130/0.4) usage as the priming solution on renal function in children undergoing cardiac surgery. Ren Fail. 2013;35(2):210-5. doi: 10.3109/0886022X.2012.747139. Epub 2012 Dec 11.'}, {'pmid': '23044498', 'type': 'BACKGROUND', 'citation': "Alavi SM, Ahmadi BB, Baharestani B, Babaei T. Comparison of the effects of gelatin, Ringer's solution and a modern hydroxyl ethyl starch solution after coronary artery bypass graft surgery. Cardiovasc J Afr. 2012 Sep;23(8):428-31. doi: 10.5830/CVJA-2012-026."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine which priming fluid is the safest for use for priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing cardiac surgery. The fluids to be compared are albumin and voluven. A control group will receive only crystalloid.', 'detailedDescription': "Project title:\n\nComparison of priming constituents in patients undergoing CPB assisted cardiac surgery: 6% HES 130/0.4 or Albumen 5%\n\nPrincipal investigator:\n\nJo-Anne Marcoux M. Sc., CPC, CCP\n\nDepartment:\n\nClinical Perfusion\n\nSub-investigators:\n\nVictor Uppal B. Sc., CPC, CCP Taras Mycyk MD, FRCSC,\n\nResearch will be conducted at: the cardiac operating rooms of the Royal University Hospital, and affiliated hospitals\n\nHypothesis It is hypothesized that the use of an artificial colloid (6% hydroxyethyl starch 130/0.4) (HES) as a priming constituent is more disruptive to the coagulation and renal systems compared to the use of human derived albumen.\n\nIt is further hypothesized that patients who undergo cardiopulmonary bypass (CPB) with HES 130/0.4 as a priming constituent will demonstrate decreased creatinine clearance and increased post-operative bleeding and transfusion requirements.\n\nAcademic validity Permissive hemodilution results when crystalloids and colloids are substituted for blood as priming fluids in the cardiopulmonary bypass circuit. While there are obvious benefits to decreasing autologous blood exposure to the patients undergoing CPB, determining the most physiological substitution has not been conclusively resolved. Historically, available HES had a greater molecular weight then the product currently in use and was associated with detrimental adverse events when compared to saline as fluid replacement therapy (5.3% vs. 2.8%, p \\< 0.001). (1) When albumin was compared to HES 450/0.7 and HES 200/0.05 for fluid management in adult CPB surgery, (18 trials of 970 patients) HES increased transfusion of red blood cells by 28.4% (p = 0.027), increased the transfusion of fresh-frozen plasma by 30.6% (p = 0.008) and increased the transfusion of platelets by 29.8% (p = 0.027). HES 130/0.4 could not be compared to albumen in this same study because there was insufficient data collected. However, no significant differences were found when comparing transfusion requirements between HES 450/0.7, HES 200/0.05 and HES 130/0.4. (2) Viscoelastic device analysis concluded that the administration of HES 130/0.4 in patients or healthy volunteers resulted in a weaker and smaller clot. (3) Short-time infusions of HES 200/0.5 and HES 130/0.4 after cardiac surgery produced a temporary impairment of fibrin formation and clot strength while human albumin had no effect. (4)\n\nIn regards to the association between HES and renal failure, on the one hand use of HES 130/0.4 as a priming fluid used in children undergoing CPB did not result in any negative effects on renal function and was safe to use in the pediatric population. (5) On the other hand, when used for resuscitative measures in 7000 randomly assigned patients admitted to intensive care, though there was no difference in 90 day mortality between the group assigned HES 130/0.4 and the group assigned saline, more patients assigned HES 130/0.4 required renal replacement therapy. (1) When used immediately after CPB in a double-blind clinical trial comparing 4% gelatin, Ringer's solution and HES 130/0.4, it was found that significantly lower mean creatinine levels were found in the HES 130/0.4 group compared to the other two groups. (6)\n\nOur research is directed toward determining conclusively if HES 130/0.4 has a similar risk profile to HES 450/0.7 and HES 200/0.05 when used as a priming constituent for the CPB circuit. Additionally we will determine if an albumin/crystalloid prime is superior to a HES 130/0.4/crystalloid prime. A fully crystalloid prime control group will be included for a controlled comparison.\n\nResearch design/Methods\n\nThe will be a randomized, control trial. Three groups of subjects will be studied:\n\n1. Control group: Crystalloid prime\n\n * 2 L crystalloid prime,\n * 2.5 mL/kg Mannitol 20%,\n * 1 ampoule of NaHCO-3 (50 mL),\n * 10,000 iu heparin\n2. Voluven (light?):\n\n * HES 130/0.4 prime 500 mL\n * balance of crystalloid\n * 2.5 mL/kg Mannitol 20%,\n * 1 ampoule of NaHCO-3 (50 mL),\n * 10,000 iu heparin\n3. Albumin:\n\n * Human albumin 500 mL 5%\n * balance of crystalloid\n * 2.5 mL/kg Mannitol 20%,\n * 1 ampoule of NaHCO-3 (50 mL),\n * 10,000 iu heparin\n\nStatistical Analysis We would like to have 7000 subjects included in this research project. Study populations and outcomes for patients undergoing CPB assisted cardiac surgery are extremely varied. An extremely large population size will be necessary to answer the research question proposed as the priming differences in question result in very subtle outcome differences.\n\nAll patients will undergo CPB assisted cardiac surgery. Blood samples will be drawn at routine intervals from each subject. Blood will be sampled upon entering the operating room, at the completion of surgery, and at 24 hours post-operatively.\n\nThe amount of blood drawn will not be above and beyond the usual tests and analyses related to the care of all affected patients undergoing CPB assisted cardiac surgery.\n\na)\n\nInclusion criteria:\n\n* greater than 50 years of age\n* will be afflicted with co-morbidities associated with cardiac disease (increased cholesterol, hypertension, smoking, diabetes, previous myocardial infarctions and decreased ejection fraction)\n\nExclusion criteria:\n\n* emergencies\n* renal failure\n* dialysis dependent\n\nThe cardiac center involved to date is:\n\nRUH Saskatoon The goal is recruitment of all cardiac centers in western Canada.\n\nPrimary end-points: are postoperative bleeding and transfusion of autologous units of red blood cells, frozen plasma and platelets.\n\nSecondary end-points: Post-operative renal function parameter creatinine\n\nData collection will be ongoing. Interim analysis will be completed once half the patients have been recruited with final statistical analysis to be conducted once data capture is complete.\n\nPotential Significance/Justification CPB assisted cardiac surgical outcomes have improved tremendously since the first such procedure was done in 1953. Outcome improvements have always come from small changes that were evidence based. This research project means to determine the safest prime for a procedure, which occurs roughly 2,000,000/year throughout the world. In regards to the cost of the study solutions in question, there is a $4.10 difference between the cost of 500 mL of HES 130/0.4 prime and 500 mL of 5% Albumin with HES 130/0.4 being more expensive."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients undergoing cardiopulmonary bypass assisted cardiac surgery\n\n\\-\n\nExclusion Criteria:\n\nemergencies and patients in renal failure or dialysis -'}, 'identificationModule': {'nctId': 'NCT01849757', 'briefTitle': 'Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%', 'orgStudyIdInfo': {'id': 'ruh/westerncan/primestudy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Human Albumin', 'description': 'Human albumin solution used as part of the priming volume for the cardiopulmonary bypass circuit.', 'interventionNames': ['Other: Human Albumin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voluven or hydroethylstarch HES 130/0.4', 'description': 'Hydroethylstarch HES 130/0.4 used as part of the priming volume for the cardiopulmonary bypass circuit.', 'interventionNames': ['Other: Voluven']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Crystalloid', 'description': 'Crystalloid will be used to prime the cardiopulmonary bypass circuit', 'interventionNames': ['Other: prime crystalloid']}], 'interventions': [{'name': 'prime crystalloid', 'type': 'OTHER', 'otherNames': ['saline 0.9%', 'Normosol', "Ringer's lactate", 'Plasmalyte'], 'description': 'used for priming the CPB circuit', 'armGroupLabels': ['Crystalloid']}, {'name': 'Human Albumin', 'type': 'OTHER', 'otherNames': ['Albumin 5%', 'Albumin 25%'], 'description': 'Used as a constituent for priming the CPB circuit', 'armGroupLabels': ['Human Albumin']}, {'name': 'Voluven', 'type': 'OTHER', 'otherNames': ['Hydroethylstarch HES130/0.4'], 'description': 'Used as a constituent for priming the CPB circuit', 'armGroupLabels': ['Voluven or hydroethylstarch HES 130/0.4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Jo-Anne E Marcocoux, M. Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal University Hospital Foundation'}, {'name': 'Jo-Anne E Marcoux, M. Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Perfusionist M. Sc., CPC, CCP', 'investigatorFullName': 'Jo-Anne Marcoux', 'investigatorAffiliation': 'University of Saskatchewan'}}}}