Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis
NCT ID: NCT02352675
Last Updated: 2017-08-01
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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COMPLETED
40 participants
OBSERVATIONAL
2015-04-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Congenital Heart Disease
Infants with congenital heart disease (CHD) who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston Children's Hospital
Intraoperative Blood Sample
Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis
Non Congenital Heart Disease
Infants who do not have congenital heart disease (No-CHD) and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room at Boston Children's Hospital.
Intraoperative Blood Sample
Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis
Interventions
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Intraoperative Blood Sample
Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis
Eligibility Criteria
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Inclusion Criteria
* weigh over 5.0 kg
* either have CHD and are scheduled to undergo an elective cardiac catheterization lab procedure or do not have CHD and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room
Exclusion Criteria
* child in a moribund condition (American Society of Anesthesiology (ASA 5)
* children with a hematological and/or oncological disease
* Jehovah witnesses
* children with preoperative coagulopathy, defined as a platelet count \< 100,000/μL, fibrinogen level \< 100 mg/dL, prothrombin time (PT) and activated partial thromboplastin time (PTT) \> 1.5 normal range
2 Months
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.
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.
Ngaage DL, Bland JM. Lessons from aprotinin: is the routine use and inconsistent dosing of tranexamic acid prudent? Meta-analysis of randomised and large matched observational studies. Eur J Cardiothorac Surg. 2010 Jun;37(6):1375-83. doi: 10.1016/j.ejcts.2009.11.055. Epub 2010 Feb 1.
Eaton MP. Antifibrinolytic therapy in surgery for congenital heart disease. Anesth Analg. 2008 Apr;106(4):1087-100. doi: 10.1213/ane.0b013e3181679555.
Faraoni D, Willems A, Melot C, De Hert S, Van der Linden P. Efficacy of tranexamic acid in paediatric cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Nov;42(5):781-6. doi: 10.1093/ejcts/ezs127. Epub 2012 Apr 24.
Faraoni D, Goobie SM. New insights about the use of tranexamic acid in children undergoing cardiac surgery: from pharmacokinetics to pharmacodynamics. Anesth Analg. 2013 Oct;117(4):760-762. doi: 10.1213/ANE.0b013e3182a22278. No abstract available.
Faraoni D. Safety of tranexamic acid in pediatric cardiac surgery: what we do not know. Eur J Cardiothorac Surg. 2011 Dec;40(6):1550-1; author reply 1551-2. doi: 10.1016/j.ejcts.2011.03.009. Epub 2011 Apr 14. No abstract available.
Raza I, Davenport R, Rourke C, Platton S, Manson J, Spoors C, Khan S, De'Ath HD, Allard S, Hart DP, Pasi KJ, Hunt BJ, Stanworth S, MacCallum PK, Brohi K. The incidence and magnitude of fibrinolytic activation in trauma patients. J Thromb Haemost. 2013 Feb;11(2):307-14. doi: 10.1111/jth.12078.
Dekker SE, Viersen VA, Duvekot A, de Jong M, van den Brom CE, van de Ven PM, Schober P, Boer C. Lysis onset time as diagnostic rotational thromboelastometry parameter for fast detection of hyperfibrinolysis. Anesthesiology. 2014 Jul;121(1):89-97. doi: 10.1097/ALN.0000000000000229.
Other Identifiers
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P00016186
Identifier Type: -
Identifier Source: org_study_id
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