Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT05525195
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2022-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 932}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'Day 0', 'description': 'Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database'}, {'measure': 'Transfusion requirements', 'timeFrame': 'Day 0', 'description': 'Transfusion requirements of packed red cells ( in mL), fresh frozen plasma (in mL) and platelets (in mL) during the first 24h (day 0) will be extracted from our database'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery', 'Congenital Heart Disease', 'Cardiopulmonary Bypass', 'Fibrinogenemia']}, 'referencesModule': {'references': [{'pmid': '28101869', 'type': 'BACKGROUND', 'citation': 'Weisel JW, Litvinov RI. Fibrin Formation, Structure and Properties. Subcell Biochem. 2017;82:405-456. doi: 10.1007/978-3-319-49674-0_13.'}, {'pmid': '31574543', 'type': 'BACKGROUND', 'citation': 'Grottke O, Mallaiah S, Karkouti K, Saner F, Haas T. Fibrinogen Supplementation and Its Indications. Semin Thromb Hemost. 2020 Feb;46(1):38-49. doi: 10.1055/s-0039-1696946. Epub 2019 Oct 1.'}, {'pmid': '22100981', 'type': 'BACKGROUND', 'citation': 'Corum LE, Hlady V. The effect of upstream platelet-fibrinogen interactions on downstream adhesion and activation. Biomaterials. 2012 Feb;33(5):1255-60. doi: 10.1016/j.biomaterials.2011.10.074. Epub 2011 Nov 17.'}, {'pmid': '20849450', 'type': 'BACKGROUND', 'citation': 'Guzzetta NA, Miller BE. Principles of hemostasis in children: models and maturation. Paediatr Anaesth. 2011 Jan;21(1):3-9. doi: 10.1111/j.1460-9592.2010.03410.x. Epub 2010 Sep 16.'}, {'pmid': '33137819', 'type': 'BACKGROUND', 'citation': 'Charbonneau H, Pasquie M, Mayeur N. Preoperative plasma fibrinogen level and transfusion in cardiac surgery: a biphasic correlation. Interact Cardiovasc Thorac Surg. 2020 Nov 1;31(5):622-625. doi: 10.1093/icvts/ivaa153.'}, {'pmid': '28459785', 'type': 'BACKGROUND', 'citation': 'Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lance MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelso AJ, Wouters P, Wyffels P, Zacharowski K. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630.'}, {'pmid': '24503704', 'type': 'BACKGROUND', 'citation': 'Faraoni D, Willems A, Savan V, Demanet H, De Ville A, Van der Linden P. Plasma fibrinogen concentration is correlated with postoperative blood loss in children undergoing cardiac surgery. A retrospective review. Eur J Anaesthesiol. 2014 Jun;31(6):317-26. doi: 10.1097/EJA.0000000000000043.'}, {'pmid': '15278267', 'type': 'BACKGROUND', 'citation': 'Paparella D, Brister SJ, Buchanan MR. Coagulation disorders of cardiopulmonary bypass: a review. Intensive Care Med. 2004 Oct;30(10):1873-81. doi: 10.1007/s00134-004-2388-0. Epub 2004 Jul 24.'}, {'pmid': '28597463', 'type': 'BACKGROUND', 'citation': 'Ravn HB. Hemostasis in Pediatric Cardiac Surgery. Semin Thromb Hemost. 2017 Oct;43(7):682-690. doi: 10.1055/s-0037-1603365. Epub 2017 Jun 8. No abstract available.'}, {'pmid': '24507940', 'type': 'BACKGROUND', 'citation': 'Walden K, Jeppsson A, Nasic S, Backlund E, Karlsson M. Low preoperative fibrinogen plasma concentration is associated with excessive bleeding after cardiac operations. Ann Thorac Surg. 2014 Apr;97(4):1199-206. doi: 10.1016/j.athoracsur.2013.11.064. Epub 2014 Feb 6.'}, {'pmid': '24316606', 'type': 'BACKGROUND', 'citation': 'Gielen C, Dekkers O, Stijnen T, Schoones J, Brand A, Klautz R, Eikenboom J. The effects of pre- and postoperative fibrinogen levels on blood loss after cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014 Mar;18(3):292-8. doi: 10.1093/icvts/ivt506. Epub 2013 Dec 6.'}, {'pmid': '25600583', 'type': 'BACKGROUND', 'citation': 'Ranucci M, Jeppsson A, Baryshnikova E. Pre-operative fibrinogen supplementation in cardiac surgery patients: an evaluation of different trigger values. Acta Anaesthesiol Scand. 2015 Apr;59(4):427-33. doi: 10.1111/aas.12469. Epub 2015 Jan 20.'}, {'pmid': '31250738', 'type': 'BACKGROUND', 'citation': 'Ranucci M, Bianchi P, Cotza M, Beccaris C, Silvetti S, Isgro G, Giamberti A, Baryshnikova E. Fibrinogen levels and postoperative chest drain blood loss in low-weight (<10 kg) children undergoing cardiac surgery. Perfusion. 2019 Nov;34(8):629-636. doi: 10.1177/0267659119854246. Epub 2019 Jun 28.'}, {'pmid': '28359027', 'type': 'BACKGROUND', 'citation': 'Spiezia L, Di Gregorio G, Campello E, Maggiolo S, Bortolussi G, Stellin G, Simioni P, Vida V. Predictors of postoperative bleeding in children undergoing cardiopulmonary bypass: A preliminary Italian study. Thromb Res. 2017 May;153:85-89. doi: 10.1016/j.thromres.2017.03.021. Epub 2017 Mar 22.'}, {'pmid': '30904398', 'type': 'BACKGROUND', 'citation': 'Willems A, Patte P, De Groote F, Van der Linden P. Cyanotic heart disease is an independent predicting factor for fresh frozen plasma and platelet transfusion after cardiac surgery. Transfus Apher Sci. 2019 Jun;58(3):304-309. doi: 10.1016/j.transci.2019.03.014. Epub 2019 Mar 19.'}, {'pmid': '28393783', 'type': 'BACKGROUND', 'citation': 'Bhardwaj V, Malhotra P, Hasija S, Chowdury UK, Pangasa N. Coagulopathies in cyanotic cardiac patients: An analysis with three point - of - care testing devices (Thromboelastography, rotational thromboelastometry, and sonoclot analyzer). Ann Card Anaesth. 2017 Apr-Jun;20(2):212-218. doi: 10.4103/aca.ACA_4_17.'}, {'pmid': '25886765', 'type': 'BACKGROUND', 'citation': 'Van der Linden P, Dumoulin M, Van Lerberghe C, Torres CS, Willems A, Faraoni D. Efficacy and safety of 6% hydroxyethyl starch 130/0.4 (Voluven) for perioperative volume replacement in children undergoing cardiac surgery: a propensity-matched analysis. Crit Care. 2015 Mar 17;19(1):87. doi: 10.1186/s13054-015-0830-z.'}, {'pmid': '17442904', 'type': 'BACKGROUND', 'citation': 'Lacroix J, Hebert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ; TRIPICU Investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators Network. Transfusion strategies for patients in pediatric intensive care units. N Engl J Med. 2007 Apr 19;356(16):1609-19. doi: 10.1056/NEJMoa066240.'}, {'pmid': '19789443', 'type': 'BACKGROUND', 'citation': 'Willems A, Harrington K, Lacroix J, Biarent D, Joffe AR, Wensley D, Ducruet T, Hebert PC, Tucci M; TRIPICU investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Comparison of two red-cell transfusion strategies after pediatric cardiac surgery: a subgroup analysis. Crit Care Med. 2010 Feb;38(2):649-56. doi: 10.1097/CCM.0b013e3181bc816c.'}, {'pmid': '27818791', 'type': 'BACKGROUND', 'citation': 'Scrucca L, Fop M, Murphy TB, Raftery AE. mclust 5: Clustering, Classification and Density Estimation Using Gaussian Finite Mixture Models. R J. 2016 Aug;8(1):289-317.'}]}, 'descriptionModule': {'briefSummary': "Fibrinogen plays an important role in the coagulation cascade. Low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery. Guidelines from the European Society of Anesthesiology and Intensive Care recommends fibrinogen substitution based on viscoelastic tests in adult cardiac surgery. Cardiopulmonary bypass results in a profound hemodilution and dilution of all coagulation factors. This is especially true in children where the priming volume of the cardiopulmonary bypass circuit is much higher compared to the patient's weight than in adults. Cardiopulmonary bypass generates high levels of tissue plasminogen activator resulting in a hyperfibrinolysis, further lowering fibrinogen levels.\n\nThe aim of this retrospective study is to explore a possible relationship between preoperative fibrinogen levels and perioperative blood loss, as well as transfusion requirements in children undergoing cardiac surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children under 16 year, with cardiac surgery under cardiopulmonary bypass between 2008 and 2018 at our institution', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* all children with cardiac surgery under cardiopulmonary bypass between 2008 and 2018\n* Age \\< 16 year\n\nExclusion Criteria:\n\n* preoperative coagulopathy\n* Jehovah's witnesses\n* patients with fresh frozen plasma in the priming of the cardiopulmonary bypass circuit"}, 'identificationModule': {'nctId': 'NCT05525195', 'briefTitle': 'Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Influence of Preoperative Fibrinogen Levels on Blood Loss and Transfusions in Pediatric Cardiac Surgery', 'orgStudyIdInfo': {'id': 'card_ped_fibri'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Congenital cardiac surgery', 'type': 'PROCEDURE', 'description': 'All children who underwent congenital cardiac surgery with cardiopulmonary bypass between 2008 and 2018'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Universitaire des Enfants Reine Fabiola', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Bernard Wenderickx, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HUDERF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department, anesthesiology', 'investigatorFullName': 'Denis SCHMARTZ', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}