Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery
NCT ID: NCT02352662
Last Updated: 2017-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-04-30
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Group
Three blood samples will be collected intra-operatively from each subject enrolled
Perioperative blood samples collection
Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation
Interventions
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Perioperative blood samples collection
Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation
Eligibility Criteria
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Inclusion Criteria
* Patients equal to or less than 12 months of age
* Undergoing elective cardiac surgery with cardiopulmonary bypass
Exclusion Criteria
* The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))
12 Months
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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David Faraoni
Cardiac Anesthesiologist
Principal Investigators
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David Faraoni, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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References
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Miller BE, Mochizuki T, Levy JH, Bailey JM, Tosone SR, Tam VK, Kanter KR. Predicting and treating coagulopathies after cardiopulmonary bypass in children. Anesth Analg. 1997 Dec;85(6):1196-202. doi: 10.1097/00000539-199712000-00003.
Faraoni D, Willems A, Romlin BS, Belisle S, Van der Linden P. Development of a specific algorithm to guide haemostatic therapy in children undergoing cardiac surgery: a single-centre retrospective study. Eur J Anaesthesiol. 2015 May;32(5):320-9. doi: 10.1097/EJA.0000000000000179.
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.
Arnold P. Treatment and monitoring of coagulation abnormalities in children undergoing heart surgery. Paediatr Anaesth. 2011 May;21(5):494-503. doi: 10.1111/j.1460-9592.2010.03461.x. Epub 2010 Dec 1.
Osthaus WA, Boethig D, Johanning K, Rahe-Meyer N, Theilmeier G, Breymann T, Suempelmann R. Whole blood coagulation measured by modified thrombelastography (ROTEM) is impaired in infants with congenital heart diseases. Blood Coagul Fibrinolysis. 2008 Apr;19(3):220-5. doi: 10.1097/MBC.0b013e3282f54532.
Faraoni D, Savan V, Levy JH, Theusinger OM. Goal-directed coagulation management in the perioperative period of cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1347-54. doi: 10.1053/j.jvca.2013.08.005. Epub 2013 Oct 5. No abstract available.
Gorlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology. 2011 Dec;115(6):1179-91. doi: 10.1097/ALN.0b013e31823497dd.
Williams GD, Bratton SL, Ramamoorthy C. Factors associated with blood loss and blood product transfusions: a multivariate analysis in children after open-heart surgery. Anesth Analg. 1999 Jul;89(1):57-64. doi: 10.1097/00000539-199907000-00011.
Hayashi T, Sakurai Y, Fukuda K, Yada K, Ogiwara K, Matsumoto T, Yoshizawa H, Takahashi Y, Yoshikawa Y, Hayata Y, Taniguchi S, Shima M. Correlations between global clotting function tests, duration of operation, and postoperative chest tube drainage in pediatric cardiac surgery. Paediatr Anaesth. 2011 Aug;21(8):865-71. doi: 10.1111/j.1460-9592.2011.03524.x. Epub 2011 Jan 21.
Jensen AS, Johansson PI, Bochsen L, Idorn L, Sorensen KE, Thilen U, Nagy E, Furenas E, Sondergaard L. Fibrinogen function is impaired in whole blood from patients with cyanotic congenital heart disease. Int J Cardiol. 2013 Sep 1;167(5):2210-4. doi: 10.1016/j.ijcard.2012.06.019. Epub 2012 Jun 22.
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.
Faraoni D, Van der Linden P. Factors affecting postoperative blood loss in children undergoing cardiac surgery. J Cardiothorac Surg. 2014 Feb 11;9:32. doi: 10.1186/1749-8090-9-32.
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.
Other Identifiers
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IRB-P00016002
Identifier Type: -
Identifier Source: org_study_id
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