Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
NCT ID: NCT02822599
Last Updated: 2021-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2017-06-01
2020-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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RiaSTAP
Group 1 will receive an infusion of RiaSTAP after termination of CPB at a dose of 70 mg/kg after randomization to this group.
RiaStAP
To decrease post-operative bleeding volume.
Saline
Group 2 will receive a placebo consisting of Normal Saline 0.9% (NS) after randomization to this group.
Saline
Placebo consisting of normal saline 0.9%
Interventions
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RiaStAP
To decrease post-operative bleeding volume.
Saline
Placebo consisting of normal saline 0.9%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
1 Year
ALL
No
Sponsors
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Nicklaus Children's Hospital f/k/a Miami Children's Hospital
OTHER
Responsible Party
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Christopher Tirotta, MD, MBA
Director Cardiac Anesthesia
Principal Investigators
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Christopher Tirotta, MD
Role: PRINCIPAL_INVESTIGATOR
Director Cardiac Anesthesia
Locations
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Nickalus Children's Hospital f/k/a Miami Children's Hospital
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Countries
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References
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Dacey LJ, Munoz JJ, Baribeau YR, Johnson ER, Lahey SJ, Leavitt BJ, Quinn RD, Nugent WC, Birkmeyer JD, O'Connor GT. Reexploration for hemorrhage following coronary artery bypass grafting: incidence and risk factors. Northern New England Cardiovascular Disease Study Group. Arch Surg. 1998 Apr;133(4):442-7. doi: 10.1001/archsurg.133.4.442.
Moulton MJ, Creswell LL, Mackey ME, Cox JL, Rosenbloom M. Reexploration for bleeding is a risk factor for adverse outcomes after cardiac operations. J Thorac Cardiovasc Surg. 1996 May;111(5):1037-46. doi: 10.1016/s0022-5223(96)70380-x.
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.
Miller BE, Tosone SR, Guzzetta NA, Miller JL, Brosius KK. Fibrinogen in children undergoing cardiac surgery: is it effective? Anesth Analg. 2004 Nov;99(5):1341-1346. doi: 10.1213/01.ANE.0000134811.27812.F0.
Kern FH, Morana NJ, Sears JJ, Hickey PR. Coagulation defects in neonates during cardiopulmonary bypass. Ann Thorac Surg. 1992 Sep;54(3):541-6. doi: 10.1016/0003-4975(92)90451-9.
Chan AK, Leaker M, Burrows FA, Williams WG, Gruenwald CE, Whyte L, Adams M, Brooker LA, Adams H, Mitchell L, Andrew M. Coagulation and fibrinolytic profile of paediatric patients undergoing cardiopulmonary bypass. Thromb Haemost. 1997 Feb;77(2):270-7.
Karlsson M, Ternstrom L, Hyllner M, Baghaei F, Nilsson S, Jeppsson A. Plasma fibrinogen level, bleeding, and transfusion after on-pump coronary artery bypass grafting surgery: a prospective observational study. Transfusion. 2008 Oct;48(10):2152-8. doi: 10.1111/j.1537-2995.2008.01827.x. Epub 2008 Jul 24.
Karlsson M, Ternstrom L, Hyllner M, Baghaei F, Flinck A, Skrtic S, Jeppsson A. Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. A prospective randomised pilot study. Thromb Haemost. 2009 Jul;102(1):137-44. doi: 10.1160/TH08-09-0587.
Rahe-Meyer N, Pichlmaier M, Haverich A, Solomon C, Winterhalter M, Piepenbrock S, Tanaka KA. Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level: a pilot study. Br J Anaesth. 2009 Jun;102(6):785-92. doi: 10.1093/bja/aep089. Epub 2009 May 2.
Tirotta CF, Lagueruela RG, Gupta A, Salyakina D, Aguero D, Ojito J, Kubes K, Hannan R, Burke RP. A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass. Pediatr Cardiol. 2022 Oct;43(7):1444-1454. doi: 10.1007/s00246-022-02866-4. Epub 2022 Mar 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Nicklaus Children's Hospital
Other Identifiers
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NCH0000201496
Identifier Type: -
Identifier Source: org_study_id
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