Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT01078818
Status:
COMPLETED
Last Update Posted:
2010-03-03
First Post:
2010-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}, {'id': 'C031621', 'term': 'ferrous fumarate'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-02', 'studyFirstSubmitDate': '2010-03-01', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemoglobin and Hematocrit values', 'timeFrame': '2 years', 'description': 'The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass'}], 'secondaryOutcomes': [{'measure': 'need for hemoderived blood transfusions, postoperative stay and hospital costs', 'timeFrame': '2 years', 'description': 'The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Extracorporeal circulation', 'Anaemia', 'Intravenous iron', 'Oral Iron'], 'conditions': ['Anaemia']}, 'referencesModule': {'references': [{'pmid': '358883', 'type': 'BACKGROUND', 'citation': 'Reuler JB. Hypothermia: pathophysiology, clinical settings, and management. Ann Intern Med. 1978 Oct;89(4):519-27. doi: 10.7326/0003-4819-89-4-519.'}, {'pmid': '8694618', 'type': 'BACKGROUND', 'citation': 'Huyzen RJ, van Oeveren W, Wei F, Stellingwerf P, Boonstra PW, Gu YJ. In vitro effect of hemodilution on activated clotting time and high-dose thrombin time during cardiopulmonary bypass. Ann Thorac Surg. 1996 Aug;62(2):533-7.'}, {'pmid': '6990115', 'type': 'BACKGROUND', 'citation': 'Kirklin JW. Open-heart surgery at the Mayo Clinic. The 25th anniversary. Mayo Clin Proc. 1980 May;55(5):339-41. No abstract available.'}, {'pmid': '7453783', 'type': 'BACKGROUND', 'citation': 'Chenoweth DE, Cooper SW, Hugli TE, Stewart RW, Blackstone EH, Kirklin JW. Complement activation during cardiopulmonary bypass: evidence for generation of C3a and C5a anaphylatoxins. N Engl J Med. 1981 Feb 26;304(9):497-503. doi: 10.1056/NEJM198102263040901.'}, {'pmid': '8431082', 'type': 'BACKGROUND', 'citation': 'Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. doi: 10.1016/0003-4975(93)91048-r.'}, {'pmid': '1377956', 'type': 'BACKGROUND', 'citation': 'Fuhrer G, Gallimore MJ, Heller W, Hoffmeister HE. Aprotinin in cardiopulmonary bypass--effects on the Hageman factor (FXII)--Kallikrein system and blood loss. Blood Coagul Fibrinolysis. 1992 Feb;3(1):99-104. doi: 10.1097/00001721-199202000-00014.'}, {'pmid': '9066432', 'type': 'BACKGROUND', 'citation': 'Boyle EM Jr, Lille ST, Allaire E, Clowes AW, Verrier ED. Endothelial cell injury in cardiovascular surgery: atherosclerosis. Ann Thorac Surg. 1997 Mar;63(3):885-94. doi: 10.1016/s0003-4975(97)00057-x.'}, {'pmid': '3600716', 'type': 'BACKGROUND', 'citation': 'Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. N Engl J Med. 1987 Jul 23;317(4):249-51. doi: 10.1056/NEJM198707233170416. No abstract available.'}, {'pmid': '10532600', 'type': 'BACKGROUND', 'citation': 'Bracey AW, Radovancevic R, Riggs SA, Houston S, Cozart H, Vaughn WK, Radovancevic B, McAllister HA Jr, Cooley DA. Lowering the hemoglobin threshold for transfusion in coronary artery bypass procedures: effect on patient outcome. Transfusion. 1999 Oct;39(10):1070-7. doi: 10.1046/j.1537-2995.1999.39101070.x.'}, {'pmid': '11130261', 'type': 'BACKGROUND', 'citation': 'Fishbane S, Kowalski EA. The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Semin Dial. 2000 Nov-Dec;13(6):381-4. doi: 10.1046/j.1525-139x.2000.00104.x.'}, {'pmid': '10982248', 'type': 'BACKGROUND', 'citation': 'Rohling RG, Zimmermann AP, Breymann C. Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. J Hematother Stem Cell Res. 2000 Aug;9(4):497-500. doi: 10.1089/152581600419161.'}, {'pmid': '14973801', 'type': 'BACKGROUND', 'citation': 'Madi-Jebara SN, Sleilaty GS, Achouh PE, Yazigi AG, Haddad FA, Hayek GM, Antakly MC, Jebara VA. Postoperative intravenous iron used alone or in combination with low-dose erythropoietin is not effective for correction of anemia after cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Feb;18(1):59-63. doi: 10.1053/j.jvca.2003.10.012.'}, {'pmid': '10910892', 'type': 'BACKGROUND', 'citation': 'Goodnough LT, Skikne B, Brugnara C. Erythropoietin, iron, and erythropoiesis. Blood. 2000 Aug 1;96(3):823-33.'}, {'pmid': '10607817', 'type': 'BACKGROUND', 'citation': 'Andrews NC. Disorders of iron metabolism. N Engl J Med. 1999 Dec 23;341(26):1986-95. doi: 10.1056/NEJM199912233412607. No abstract available.'}, {'pmid': '22940889', 'type': 'DERIVED', 'citation': 'Garrido-Martin P, Nassar-Mansur MI, de la Llana-Ducros R, Virgos-Aller TM, Rodriguez Fortunez PM, Avalos-Pinto R, Jimenez-Sosa A, Martinez-Sanz R. The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial. Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):1013-8. doi: 10.1093/icvts/ivs344. Epub 2012 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.', 'detailedDescription': 'Prospective double dummy triple blind study of 159 patients undergoing CPB; randomised in 3 groups treated with iron intravenously (iv) (group I), with iron orally (group II) controlled with placebo (group III). Patients from group I were treated with iv Iron sucrose , three doses of 100 mg of iv iron every 24 hours during postoperative hospitalization and 1 pill/24 h of oral placebo during the first month after discharge. Group II was programmed to receive 1 iron pill orally every 24 hours pre and postoperatively and up to one month after discharge and a placebo while hospitalized. Group III was programmed to receive an oral and iv placebo pre and postoperatively.\n\nVariables were collected preoperatively, at operation room and at Intensive Care Unit admission and discharge, at postoperative floor discharge and at one month after surgical discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 years of age\n* Patients subject to elective cardiac surgery under extracorporeal circulation\n* Patients without previous anaemia, susceptible of treatment\n* Patients without need of blood transfusion preoperative\n* Patients providing written informed consent\n* Patients who are able to complete all study visits per protocol\n\nExclusion Criteria:\n\n* Patients subject to elective cardiac surgery, but without extracorporeal circulation\n* Patients who were treated with fibrinolytic therapy 48 hours before the surgery\n* Patients with history of impaired renal function, (e.g., calculated creatinine clearance \\<50 mL/min/1.73 m2)\n* Patients operated of active endocarditis\n* Redo-surgery patients\n* Women who are pregnant or lactating\n* Patients with clinical of digestive bleeding\n* Patients with vitamin B12 deficit\n* Patients with ferropenic anaemia\n* Patients with clinical history of asthma or allergy\n* Patients with active infection\n* Patients who are included in another clinical study\n* Patients with hepatic disease\n* Patients with history of allergy to iron\n* Patients unlikely to adhere to protocol follow-up'}, 'identificationModule': {'nctId': 'NCT01078818', 'briefTitle': 'Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Canaria Rafael Clavijo para la Investigación Biomédica'}, 'officialTitle': 'A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery', 'orgStudyIdInfo': {'id': 'Tratamiento con hierro/2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV trivalent saccharose hydroxide ferrous', 'interventionNames': ['Drug: IV trivalent saccharose hydroxide ferrous']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral ferrous fumarate', 'interventionNames': ['Drug: Oral ferrous fumarate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral and intravenous Placebo', 'interventionNames': ['Drug: Oral and intravenous Placebo']}], 'interventions': [{'name': 'IV trivalent saccharose hydroxide ferrous', 'type': 'DRUG', 'otherNames': ['Venofer'], 'description': 'Preoperative Period 5-10 days 200 mg Iron iv (Venofer® )in 200cc physiologic solution /24-48h x 3 dosis +1 oral placebo /24h Postoperative Period 1-3weeks 200 mg Iron iv (Venofer® )in 200cc physiologic solution/24-48h x 3 dosis + 1 oral placebo /24h One month Follow-up\n\n1 month 1 oral placebo /24h', 'armGroupLabels': ['IV trivalent saccharose hydroxide ferrous']}, {'name': 'Oral ferrous fumarate', 'type': 'DRUG', 'description': '200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®)\n\nPostoperative Period:\n\n200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) One month Follow-up: 1 oral iron tablet/24h Ferogradumet', 'armGroupLabels': ['Oral ferrous fumarate']}, {'name': 'Oral and intravenous Placebo', 'type': 'DRUG', 'description': 'Preoperative Period:1oral placebo/24h Postoperative Period:200cc physiologic solution iv placebo /24-48h x 3 dosis + 1oral placebo/24h One month Follow-up:1 oral placebo/24h', 'armGroupLabels': ['Oral and intravenous Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38320', 'city': 'Santa Cruz de Tenerife', 'state': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}], 'overallOfficials': [{'name': 'Pilar Garrido, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario de Canarias'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Canaria Rafael Clavijo para la Investigación Biomédica', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pilar Garrido Martin MD', 'oldOrganization': 'Fundación Canaria Rafael Clavijo para la Investigación Biomédica'}}}}