Clinical trial NCT02822599: Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
Official title: The Role of Human Fibrinogen Concentrate (RiaSTAP) in Decreasing Blood Loss and the Need for Component Blood Therapy in Infants Undergoing Cardiopulmonary Bypass.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypofibrinogenemia
Afibrinogenemia
Bleeding Disorders
Keywords: CBP, congenital heart defects, cardiopulmonary bypass
Lead sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.

Detailed description: The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass. RiaSTAP will be administered after termination of Cardiopulmonary Bypass (CPB) at a dose of 70 mg/kg, in a prospective, randomized, controlled study. We hypothesize that the administration of RiaSTAP in this manner will reduce peri-operative bleeding and transfusion requirements.

Eligibility criteria: Inclusion Criteria:

* Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus Children's Hospital will be eligible for enrollment in the study.

Exclusion Criteria:

* Patients who fall outside of the age range for the study will be excluded. Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM MCF \> 15mm, will be excluded.

Primary outcomes:
measure: Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL))
timeFrame: Within 24 hours of surgery
measure: Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure
timeFrame: 2 hour
measure: Post-operative 24-hr Hemoglobin (Hg) mg/dL
timeFrame: 24 hr
measure: Post-operative 2 hr Hematocrit (HCT) Measure
timeFrame: 2 hour
measure: Post-operative 24 hr Hematocrit (HCT) Measure
timeFrame: 24 hour
measure: Post-operative 2 hr Platelets Count Test (PLT) 10K/uL
timeFrame: 2 hour
measure: Post-operative 24 hr Platelets Count Test (PLT) 10K/uL
timeFrame: 24 hour
measure: Post-operative 2 hr Prothrombin (PT) Seconds
timeFrame: 2 hour
measure: Post-operative 24 hr Prothrombin (PT) Seconds
timeFrame: 24 hour
measure: Post-operative 2 hr International Normalize Ratio (INR)
timeFrame: 2 hour
measure: Post-operative 24 hr International Normalize Ratio (INR)
timeFrame: 24 hour
measure: Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds
timeFrame: 2 hour
measure: Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds
timeFrame: 24 hour
measure: Post-operative 2 hr Fibrinogen mg/dL
timeFrame: 2 hour
measure: Post-operative 24 hr Fibrinogen mg/dL
timeFrame: 24 hour
Secondary outcomes:
measure: Post-Operative Respiratory Failure Adverse Events
timeFrame: 24 hours after surgery
measure: Post-operative Thrombus Adverse Events
timeFrame: within 24 hours of surgery
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nickalus Children's Hospital f/k/a Miami Children's Hospital
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
Study officials:
affiliation: Director Cardiac Anesthesia
name: Christopher Tirotta, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.