Efficacy of tranexamic acid in pediatric craniosynostosis surgery: A double-blind, placebo-controlled trial

Anesthesiology

Volumn 114, Issue 4, 2011, Pages 862-871

  Goobie, Susan M ^a   Meier, Petra M ^a   Pereira, Luis M ^c   McGowan, Francis X ^a   Prescilla, Randy P ^a   Scharp, Laurie A ^a   Rogers, Gary F ^b   Proctor, Mark R ^a   Meara, John G ^b   Soriano, Sulpicio G ^a   Zurakowski, David ^a   Sethna, Navil F ^a  

^a BOSTON CHILDREN S HOSPITAL   (United States)

^b Department of Plastic and Oral Surgery ^*  (United States)

^c Department of Pharmacometrics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; PLASMIN; TRANEXAMIC ACID;

ARTICLE; BLEEDING; BLOOD TRANSFUSION; CHILD; CHILD HOSPITALIZATION; CLINICAL ARTICLE; CONTROLLED STUDY; CRANIOFACIAL SYNOSTOSIS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG EFFICACY; ERYTHROCYTE CONCENTRATE; FEMALE; FIBRINOLYSIS; HUMAN; INFANT; LOADING DRUG DOSE; MALE; PARALLEL DESIGN; PEDIATRIC SURGERY; PERIOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTE ACTIVATION; TREATMENT OUTCOME;

EID: 79953220798     PISSN: 00033022     EISSN: 15281175     Source Type: Journal    
DOI: 10.1097/ALN.0b013e318210fd8f     Document Type: Article

References (53)

1. Chadduck WM: Craniosynostosis, Pediatric Neurosurgery, 3rd Edition. Edited by Cheek WR. Philadelphia, WB Saunders, 1994, pp 111-23
2. Reiner D: Intracranial pressure in craniosynostosis: Pre-and postoperative recordings-correlation with functional results, Scientific Foundations and Surgical Treatment of Craniosynostosis. Edited by Persing JA, Edgerton MT, Jane JA. Baltimore, Williams & Wilkins, 1989, pp 263-9
3. White N, Marcus R, Dover S, Solanki G, Nishikawa H, Millar C, Carver ED: Predictors of blood loss in fronto-orbital advancement and remodeling. J Craniofac Surg 2009; 20: 378-81
4. Vamvakas EC: Long-term survival rate of pediatric patients after blood transfusion. Transfusion 2008; 48:2478-80
5. Czerwinski M, Hopper RA, Gruss J, Fearon JA: Major morbidity and mortality rates in craniofacial surgery: An analysis of 8101 major procedures. Plast Reconstr Surg 2010; 126:181-6
6. Stricker PA, Shaw TL, Desouza DG, Hernandez SV, Bartlett SP, Friedman DF, Sesok-Pizzini DA, Jobes DR: Blood loss, replacement, and associated morbidity in infants and children undergoing craniofacial surgery. Paediatr Anaesth 2010; 20:150-9
7. Phillips RJ, Mulliken JB: Venous air embolism during a craniofacial procedure. Plast Reconstr Surg 1988; 82:155-9
8. Faberowski LW, Black S, Mickle JP: Blood loss and transfusion practice in the perioperative management of craniosynostosis repair. J Neurosurg Anesthesiol 1999; 11:167-72 (Pubitemid 29300293)
9. Ririe DG, Lantz PE, Glazier SS, Argenta LC: Transfusionrelated acute lung injury in an infant during craniofacial surgery. Anesth Analg 2005; 101:1003-6 (Pubitemid 41383061)
10. Tunçbilek G, Vargel I, Erdem A, Mavili ME, Benli K, Erk Y: Blood loss and transfusion rates during repair of craniofacial deformities. J Craniofac Surg 2005; 16:59-62 (Pubitemid 40976057)
11. Williams GD, Ellenbogen RG, Gruss JS: Abnormal coagulation during pediatric craniofacial surgery. Pediatr Neurosurg 2001; 35:5-12 (Pubitemid 32722313)
12. Buntain SG, Pabari M: Massive transfusion and hyperkalaemic cardiac arrest in craniofacial surgery in a child. Anaesth Intensive Care 1999; 27:530-3 (Pubitemid 29467011)
13. Henry D, Carless P, Fergusson D, Laupacis A: The safety of aprotinin and lysine-derived antifibrinolytic drugs in cardiac surgery: A meta-analysis. CMAJ 2009; 180:183-93
14. Schouten ES, van de Pol AC, Schouten AN, Turner NM, Jansen NJ, Bollen CW: The effect of aprotinin, tranexamic acid, and aminocaproic acid on blood loss and use of blood products in major pediatric surgery: A meta-analysis. Pediatr Crit Care Med 2009; 10:182-90
15. Dunn CJ, Goa KL: Tranexamic acid: A review of its use in surgery and other indications. Drugs 1999; 57:1005-32 (Pubitemid 29313210)
16. Cyklokapron [package insert]. New York: Pharmacia and Upjohn Co; 2008
17. Tzortzopoulou A, Cepeda MS, Schumann R, Carr DB: Antifibrinolytic agents for reducing blood loss in scoliosis surgery in children. Cochrane Database Syst Rev 2008: CD006883
18. Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F: Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. ANESTHESIOLOGY 2005; 102:727-32 (Pubitemid 40462851)
19. Johnson TN: The problems in scaling adult drug doses to children. Arch Dis Child 2008; 93:207-11 (Pubitemid 352025489)
20. Practice Guidelines for blood component therapy: A report by the American Society of Anesthesiologists Task Force on Blood Component Therapy. ANESTHESIOLOGY 1996; 84:732-47
21. Davey JF, Ersser RS: Amino acid analysis of physiological fluids by high-performance liquid chromatography with phenylisothiocyanate derivatization and comparison with ion-exchange chromatography. J Chromatogr 1990; 528:9-23 (Pubitemid 20192863)
22. Dowd NP, Karski JM, Cheng DC, Carroll JA, Lin Y, James RL, Butterworth J: Pharmacokinetics of tranexamic acid during cardiopulmonary bypass. ANESTHESIOLOGY 2002; 97:390-9 (Pubitemid 34847752)
23. Kearney RA, Rosales JK, Howes WJ: Craniosynostosis: An assessment of blood loss and transfusion practices. Can J Anaesth 1989; 36:473-7 (Pubitemid 19184322)
24. Eaton MP: Antifibrinolytic therapy in surgery for congenital heart disease. Anesth Analg 2008; 106:1087-100 (Pubitemid 351450530)
25. Blood components, Blood Transfusion Therapy: A Physician's Handbook 7th edition. Edited by Triulzi DJ, Aysola A, American Association of Blood Banks. Bethesda, American Association of Blood Banks, 2002, pp 1-37
26. Lilliefors H: On the Kolmogorov-Smirnov test for normality with mean and variance unknown. J Am Stat Assoc 1967; 62:399-402
27. Katz MH: Multivariable Analysis: A Practical Guide for Clinicians, 2nd edition. Cambridge, England, Cambridge University Press, 2006, pp 96-116
28. Chatterjee S, Hadi AS: Regression Analysis by Example, 4th edition. New York, Wiley Interscience, 2006, pp 53-84
29. Browner WS, Newton TB, Cummings SR, Hulley SB: Estimating Sample Size and Power: The Nittygritty, Designing Clinical Research, 2nd edition. Edited by Hully S, Cummings S, Browner W, Grady D, Hearst N, Newman T. Philadelphia, Lippincott Williams & Wilkins, 2001, pp 65-91
30. Andersson L, Nilsoon IM, Colleen S, Granstrand B, Melander B: Role of urokinase and tissue activator in sustaining bleeding and the management thereof with EACA and AMCA. Ann N Y Acad Sci 1968; 146:642-58
31. Andersson L, Eriksson O, Hedlund PO, Kjellman H, Lindqvist B: Special considerations with regard to the dosage of tranexamic acid in patients with chronic renal diseases. Urol Res 1978; 6:83-8 (Pubitemid 8326077)
32. Soslau G, Horrow J, Brodsky I: Effect of tranexamic acid on platelet ADP during extracorporeal circulation. Am J Hematol 1991; 38:113-9
33. Livingston EH, Lee S: Percentage of burned body surface area determination in obese and nonobese patients. J Surg Res 2000; 91:106-10 (Pubitemid 30445582)
34. Fearon JA, Weinthal J: The use of recombinant erythropoietin in the reduction of blood transfusion rates in craniosynostosis repair in infants and children. Plast Reconstr Surg 2002; 109:2190-6 (Pubitemid 34556189)
35. Meneghini L, Zadra N, Aneloni V, Metrangolo S, Faggin R, Giusti F: Erythropoietin therapy and acute preoperative normovolaemic haemodilution in infants undergoing craniosynostosis surgery. Paediatr Anaesth 2003; 13:392-6 (Pubitemid 36774018)
36. Krajewski K, Ashley RK, Pung N, Wald S, Lazareff J, Kawamoto HK, Bradley JP: Successful blood conservation during craniosynostotic correction with dual therapy using procrit and cell saver. J Craniofac Surg 2008; 19:101-5 (Pubitemid 351158805)
37. Przybylo HJ, Przybylo JH: The use of recombinant erythropoietin in the reduction of transfusion rates in craniosynostosis repair in infants and children. Plast Reconstr Surg 2003; 111:2485-6; author reply 2486-7
38. Velardi F, Di Chirico A, Di Rocco C, Fundaro C, Serafini R, Piastra M, Viola L, Pietrini D, Pusateri A, Stoppa F: "No allogeneic blood transfusion" protocol for the surgical correction of craniosynostoses. I. Rationale. Childs Nerv Syst 1998; 14:722-31; discussion 740-1 (Pubitemid 29009176)
39. Jimenez DF, Barone CM: Intraoperative autologous blood transfusion in the surgical correction of craniosynostosis. Neurosurgery 1995; 37:1075-9
40. Dahmani S, Orliaguet GA, Meyer PG, Blanot S, Renier D, Carli PA: Perioperative blood salvage during surgical correction of craniosynostosis in infants. Br J Anaesth 2000; 85:550-5
41. Deva AK, Hopper RA, Landecker A, Flores R, Weiner H, McCarthy JG: The use of intraoperative autotransfusion during cranial vault remodeling for craniosynostosis. Plast Reconstr Surg 2002; 109:58-63 (Pubitemid 34056657)
42. Hans P, Collin V, Bonhomme V, Damas F, Born JD, Lamy M: Evaluation of acute normovolemic hemodilution for surgical repair of craniosynostosis. J Neurosurg Anesthesiol 2000; 12:33-6 (Pubitemid 30040839)
43. Diaz JH, Lockhart CH: Hypotensive anaesthesia for craniectomy in infancy. Br J Anaesth 1979; 51:233-5 (Pubitemid 10250436)
44. Reid RW, Zimmerman AA, Laussen PC, Mayer JE, Gorlin JB, Burrows FA: The efficacy of tranexamic acid versus placebo in decreasing blood loss in pediatric patients undergoing repeat cardiac surgery. Anesth Analg 1997; 84:990-6 (Pubitemid 27197656)
45. Gruber EM, Shukla AC, Reid RW, Hickey PR, Hansen DD: Synthetic antifibrinolytics are not associated with an increased incidence of baffle fenestration closure after the modified Fontan procedure. J Cardiothorac Vasc Anesth 2000; 14:257-9 (Pubitemid 30415921)
46. Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM: A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg 2001; 93:82-7 (Pubitemid 32601158)
47. Durán de la Fuente P, García-Fernández J, Pérez-López C, Carceller F, Gilsanz Rodríguez F: [Usefulness of tranexamic acid in cranial remodeling surgery]. Rev Esp Anestesiol Reanim 2003; 50:388-94
48. Breuer T, Martin K, Wilhelm M, Wiesner G, Schreiber C, Hess J, Lange R, Tassani P: The blood sparing effect and the safety of aprotinin compared to tranexamic acid in paediatric cardiac surgery. Eur J Cardiothorac Surg 2009; 35:167-71; author reply 171
49. Martin K, Wiesner G, Breuer T, Lange R, Tassani P: The risks of aprotinin and tranexamic acid in cardiac surgery: A oneyear follow-up of 1188 consecutive patients. Anesth Analg 2008; 107:1783-90
50. Murkin JM, Falter F, Granton J, Young B, Burt C, Chu M: High-dose tranexamic Acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg 2010; 110:350-3
51. Chauhan S, Bisoi A, Modi R, Gharde P, Rajesh MR: Tranexamic acid in paediatric cardiac surgery. Indian J Med Res 2003; 118:86-9 (Pubitemid 37493015)
52. Abrishami A, Chung F, Wong J: Topical application of antifibrinolytic drugs for on-pump cardiac surgery: A systematic review and meta-analysis. Can J Anaesth 2009; 56:202-12
53. Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F: Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: A randomized, controlled trial. J Bone Joint Surg Am 2010; 92:2503-13